THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
S U M M A R Y
DIARY: May 14, 2009 08:30 AM Thursday;
Millie meeting at UCSF assess recovery IBC with radiation hyperthermia
2...Right Breast Swelled Lymphedema Reaction Radiation Treatments
3...Ground Glass Opacities Breathing Problems Progressive Radiation Injury
4...Breathing Problems Progressive Radiation Injury Ground Glass Opacities
5...Radiation Injury Progressive Breathing Problems Ground Glass Opacities
6...CT Test Ground Glass Opacities Radiation Injury Breathing Problems
7...Comprehensive Records on Medical History Enables Comprehensive Care
8...500 Emails a Day Hectic Schedule Order Emergency Care Dying Patients
9...Cancer Treated Chronic Disease Prescribed by Primary Care Physician
10...MPA Consent Documents Treat Millie's 8th Relapse Cancer
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White Blood Cell Condition Blood Test Shows Too Low Doctor Johnson A
0403 - ..
0404 - Summary/Objective
040501 - Follow up ref SDS 74 0000. ref SDS 54 0000.
040508 - ..
0408 - Progress
040901 - Tara had reviewed correspondence on Millie's care since the prior
040902 - examination on 090423, ref SDS 74 TP9L, including both Millie's letter
040903 - to the medical team on 090510 1553 with the agenda for the meeting
040904 - today, ref SDS 75 QH9J, and the supplemental letter on 090510 1953,
040905 - that presented more details. ref SDS 76 FJ3G
040907 - ..
040908 - Tara did not receive from Kaiser the report on the lab at Kaiser for
040909 - the blood test on 090413, and she did not receive the report from
040910 - Kaiser for the CT test on 090413.
040912 - ..
040913 - Millie explained that Kaiser's report for the CT test on 090413 was
040914 - submitted to UCSF with the agenda for the meeting today in the second
040915 - letter to UCSF on 090510 1953, and which reported breathing problems.
040916 - ref SDS 76 LJ6T
040918 - ..
040919 - Tara recalled seeing Millie's letter but did not have enough time to
040920 - print the report on the CT test.
040922 - ..
040923 - Millie submitted copies of both reports received independently from
040924 - Kaiser to support the meeting today at UCSF.
040926 - ..
040927 - Generally, the CT test on 090413 shows reduced lymph nodes in right
040928 - axillary and left supraclavicular, after completing 4 weeks of intense
040929 - treatment on 090317 with radiation and hyperthermia.
040931 - ..
040932 - Blood test on 090512 shows NEUTS 1.320. ref SDS 77 B35J
040934 - ..
040935 - Tara reported findings from examination show radiaton side effects
040936 - have healed beautifully. There appears to be nearly 100% recovery
040937 - from IBC in the treated areas.
040939 - ..
040940 - There is still some bleeding from nodularity in the breastbone area
040941 - that is slower to heal than other areas, cited by Doctor Rugo on
040942 - 090401 for delaying treatment 6 weeks for Millie's 8th relapse of
040943 - cancer while waiting for the breastbone wound to heal, ref SDS 66
040944 - K56O, and reported to the medical team as still problematic in
040945 - Millie's letter on 090510 1930, submitting the agenda for the meeting
040946 - today. ref SDS 76 LJ5T
040948 - [On 090607 2253 Millie notified medical team that wound in
040949 - the breastbone area diagnosed as reaction to readiation
040950 - treatment was worse; requested additional treatment planned
040951 - by UCSF. ref SDS 89 KS62
040953 - ..
040954 - [On 090609 Doctor Hsu advises that the wound in Millie's
040955 - breastbone area is not caused by reaction to radiation
040956 - treatments; the bleeding wound was caused by a mistake
040957 - performing radiation in February and March at UCSF that
040958 - missed treating IBC in the breastbone area and this
040959 - untreated IBC tumor has caused cancer to spread, and causes
040960 - problems in Millie's lungs that prevent breathing.
040961 - ref SDS 90 TP9L
040963 - ..
040964 - Examination further shows that IBC has begun to recur on the lower
040965 - left arm, and above the left shoulder and inward to below the left
040966 - supraclavicular. There are also signs of IBC on the lower side toward
040967 - the back, just beyond the treated areas.
040970 - ..
040971 - Right Breast Swelled Lymphedema Reaction Radiation Treatments
040973 - Tara noticed today that the right breast is swelled. She commented
040974 - there is no sign that IBC has spread to the right breast, so she feels
040975 - this is continuing reaction to radiation treatments in February and
040976 - March. Tara provided guidance to treat swelling of the right breast
040977 - at home with massage to spur flow through the lymphatic system.
040979 - [...below Doctor Rugo approved home care to relieve swelling in
040980 - the right breast. ref SDS 0 AO3G
040982 - ..
040983 - CA 15-3 320 increased 50 points, ref SDS 77 PQTQ, from 271 for the lab
040984 - at Kaiser on 090413, ref SDS 69 PQTQ, compared with CA 15-3 251 for
040985 - the blood draw on 090317 and posted to the test on 090309. ref SDS 48
040986 - PQTQ
040988 - ..
040989 - Today, Doctor Rugo was about 90 minutes late, but invested about 40
040990 - minutes to plan Millie's next treatment. This is the longest time she
040991 - has visited with Millie in the past 3 years.
040993 - ..
040994 - The meeting today implements planning in Doctor Rugo's letter on
040995 - 090401 that delayed starting Millie's treatment for 6 weeks from
040996 - 090402 until today, because Doctor Hsu diagnosed the bleeding wound in
040997 - Millie's breastbone area as reaction to radiation, reported on 090401
040998 - 0121. ref SDS 66 K56O
041000 - ..
041001 - Doctor Rugo concurred with Tara's examination finding substantial
041002 - recovery from radiation side effects, which further shows recovery
041003 - from IBC in treated areas, per above, ref SDS 0 5U4H, and which
041004 - largely accomplishes objectives for getting control of the disease
041005 - using hyperthermia planned in Doctor Rugo's letter to Kaiser on
041006 - 090129, reported in the letter to the medical team on 090130.
041007 - ref SDS 31 4S8O
041009 - [On 090514 2346 Millie's letter to the medical team confirms
041010 - findings from examination today that IBC has been substantially
041011 - degraded in areas treaed with radiation and hyperthermia.
041012 - ref SDS 79 WF5Y
041014 - ..
041015 - [On 090607 2253 Millie notified medical team that wound in
041016 - the breastbone area diagnosed as reaction to readiation
041017 - treatment was worse; requested additional treatment planned
041018 - by UCSF. ref SDS 89 KS62
041020 - ..
041021 - [On 090609 Doctor Hsu advises that the wound in Millie's
041022 - breastbone area is not caused by reaction to radiation
041023 - treatments; the bleeding wound was caused by a mistake
041024 - performing radiation in February and March at UCSF that
041025 - missed treating IBC in the breastbone area and this
041026 - untreated IBC tumor has caused cancer to spread, and causes
041027 - problems in Millie's lungs that prevent breathing.
041028 - ref SDS 90 TP9L
041030 - ..
041031 - IBC and Lymphedema are both spreading on the left arm below the upper
041032 - arm treated with radiation and hyperthermia, and reflecting delay
041033 - starting the next treatment requested in Millie's letter to the
041034 - medical team on 090412 2241. ref SDS 68 9S8Y IBC is also beginning to
041035 - appear on the periphery of other treated areas roughly between the
041036 - left collar bone and the upper left shoulder, and on the left side of
041037 - the abdomen wrapping toward the back.
041039 - ..
041040 - Progression of IBC aligns with rise in cancer marker CA 15-3 320 for
041041 - the lab at Kaiser on 090512. ref SDS 77 PQTQ Doctor Rugo indicated
041042 - the rise from 271 for the prior test 3 weeks ago on 090413,
041043 - ref SDS 69 PQTQ, does not suggest rapid rise of cancer that signals
041044 - problems losing local control again, as occurred on 090129, reported
041045 - in the record the next day on 090130. ref SDS 31 4S8O Today, the
041046 - doctor explained clinical assessment observing IBC rash is critical
041047 - for applying cancer marker diagnostics to diagnose progression of
041048 - disease.
041050 - [On 090514 2346 Millie's letter to the medical team reports
041051 - Doctor Rugo's reliance on clinical examination to support
041052 - cancer marker diagnostics. ref SDS 79 WF6U
041054 - ..
041055 - Doctor Rugo noted the right breast is swelled today with edema, and
041056 - shows no sign that IBC has spread in this location. Doctor Rugo
041057 - indicated this condition most likely reflects reaction to radiation
041058 - treatments that ended on 090317. The doctor approved Tara's guidance
041059 - for home care with massage to relieve lymphedema in the right breast,
041060 - per above. ref SDS 0 AN97 Doctor Rugo further recommended physicial
041061 - therapyst consultation at Kaiser to relieve edema in the right breast.
041062 - This seems similar to Doctor Johnson, Millie's primary care physician
041063 - at Kaiser, ordered treatment with a physical therapyst to relieve
041064 - lymphedema in the left arm caused by mastectomy surgery on 051021, as
041065 - reported on 060217. ref SDS 4 T56K
041067 - [On 090514 2346 Millie's letter to the medical team reports new
041068 - findings of edema in the right breast, and no evident spread of
041069 - cancer; indicates prescription of home care, ref SDS 79 WF7Q,
041070 - and that Kaiser provide treatment with a therapyst to relieve
041071 - lymphedema in the right breast. ref SDS 79 WF7T
041073 - ..
041074 - Doctor Rugo discussed Millie's new symptoms of breathing problems,
041075 - cited in the agenda for the meeting today, submitted on 090510 1953.
041076 - ref SDS 76 LJ6T Millie asked if this could be related to cancer based
041077 - on the CT test performed at Kaiser 090413 and which found slightly
041078 - increased "ground glass opacities" in the lungs, reported on 090415
041079 - 1642. ref SDS 71 RV78
041081 - ..
041082 - Doctor Johnson at Kaiser reported on 090415 1519, that he reviewed the
041083 - scans for the CT test on 090413, and advised that there might be some
041084 - slight progression of nodules in the lungs, which he feels is reaction
041085 - to radiation. He seemed sure that the CT scans for the recent test on
041086 - 090413 do not show actual lung cancer. ref SDS 70 GT4M, and, further,
041087 - that any minimal increased nodularity should not be causing Millie
041088 - respiratory duress. ref SDS 70 8H7O
041090 - ..
041091 - Doctor Johnson confirmed his findings in a letter received later that
041092 - day on 090415 1610, ref SDS 71 YO7M, which was then distributed to the
041093 - medical team in Millie's letter the next day on 090416 0010.
041094 - ref SDS 72 835R
041097 - ..
041098 - Ground Glass Opacities Breathing Problems Progressive Radiation Injury
041099 - Breathing Problems Progressive Radiation Injury Ground Glass Opacities
041100 - Radiation Injury Progressive Breathing Problems Ground Glass Opacities
041101 - CT Test Ground Glass Opacities Radiation Injury Breathing Problems
041103 - Today, Doctor Rugo commented that Millie's new breathing problems,
041104 - reported on 090403, when Doctor Hsu requested review for pneumonia,
041105 - ref SDS 67 Z66M, and more recently on 090510, ref SDS 76 LJ6T, reflect
041106 - progression of radiation injury causing ground glass opacities in the
041107 - lungs to increase from the date of CT test findings on 090413, and
041108 - reviewed on 090415. ref SDS 71 RV78 Increasing problems with
041109 - breathing, since getting radiation at UCSF on referral from Kaiser
041110 - (reported on 090205, ref SDS 36 278T) to the chest during February and
041111 - March, correlates with increasing ground glass opacities in the lungs,
041112 - reported in the CT test on 090413, ref SDS 71 RV78, and which further
041113 - previously was stable for the past 8 years. Research on 090415
041114 - indicates radiation injury causing ground glass opacities may be
041115 - reversible with treatment. ref SDS 71 LG9L
041117 - [On 090514 2346 Millie's letter to the medical team reports
041118 - Doctor Rugo indicates ground glass opacities reported in
041119 - the CT test on 090413 are likely reaction to radiation.
041120 - ref SDS 79 WF7W
041122 - ..
041123 - [On 090609 Doctor Hsu advises there was a mistake
041124 - performing radiation in February and March at UCSF that
041125 - missed treating IBC in the breastbone area to the left of
041126 - the right breast, ref SDS 90 TP9L, and this untreated IBC
041127 - tumor may be causing problems in Millie's lungs.
041128 - ref SDS 90 W65W
041130 - ..
041131 - [On 090616 1245 Doctor Rugo requested Kaiser's radiology
041132 - report for Millie's CT test on 090612 in order to check for
041133 - progression of ground glass opacities in the lungs,
041134 - ref SDS 91 YS4J, which reflect Doctor Hsu's concern on
041135 - 090609 that medical mistakes performing radiation in
041136 - Feb-Mar failing to treat IBC in the breastbone area could
041137 - be causing problems in Millie's lungs evidenced by recent
041138 - breathing and cough problems. ref SDS 90 W65W
041140 - ..
041141 - [On 090617 1954 Millie's letter asks medical team if
041142 - "ground glass opacities" causing breathing problems will be
041143 - treated as cancer with MPA, or presents a new problem that
041144 - requires separate treatment? ref SDS 92 7J4Q
041146 - ..
041147 - [On 090618 1743 Millie's letter asks medical team for
041148 - further tests, examination, and treatment to recover from
041149 - breathing problems. ref SDS 93 TG3X
041151 - ..
041152 - [On 090708 0301 Kaiser orders xray test to evaluate
041153 - scope of Millie's breathing problems. ref SDS 94 UT6U
041155 - ..
041156 - [On 100302 0830 CT test on 100218 shows recovery from
041157 - radiation injury because ground glass opacity nodules
041158 - are reduced in Millie's lungs, aligns with improved
041159 - breathing shown by resuming hiking. ref SDS 97 FB85
041162 - ..
041163 - Comprehensive Records on Medical History Enables Comprehensive Care
041165 - Doctor Rugo noted that Millie's patient history presented to the
041166 - medical team in SDS records provides timely, accurate, comprehensive
041167 - communication that makes medical care effective. Links in SDS records
041168 - connect communication in meetings, correspondence (email), and calls,
041169 - with treatments and tests over the past 8 years. Cross referencing
041170 - patient history to subsequent events shows the chain of chronology
041171 - connecting cause and effect. Understanding context and trends aids
041172 - medical analysis for diagnosis, treatment, prognosis, and progress.
041173 - The record today illustrates communication collaboration and
041174 - cooperation through the doctor/patient partnership, per above.
041175 - ref SDS 0 TP9L Doctor Rugo described her personal "practice
041176 - preference" for thorough case management of medical details required
041177 - for comprehensive care.
041179 - ..
041180 - On 090121, Glenna called and said that Doctor Rugo wanted help finding
041181 - UCSF treatment planning using Millie's records of patient history
041182 - reporting on meetings and other communications with the medical team
041183 - the past few years. ref SDS 27 Y67L
041185 - ..
041186 - Last year on 080403, Doctor Rugo requested patient support for
041187 - communication that facilitates collaborating between doctors at Kaiser
041188 - and UCSF on Millie's care. ref SDS 10 4U9O This year on 090213 Doctor
041189 - Johnson reported that Millie presents a "stastical miracle" living 3
041190 - times longer than disease trajectory. ref SDS 39 4W72 This was
041191 - attributed to luck having strong case management, which is not
041192 - available to other patients. ref SDS 39 NY7L The following month on
041193 - 090325 Doctor Johnson confirmed Millie's luck surviving beyond disease
041194 - trajectory. ref SDS 62 P39M
041196 - ..
041197 - [On 090725 Doctor Johnson at Kaiser reported Millie's
041198 - miracle of longevity 300% beyond disease trajectory is
041199 - accomplished through "yeoman's work" of patient assistance
041200 - providing a well ordered record for accurate diagnosis,
041201 - planning, treatment, and assessment. ref SDS 95 T58R
041203 - ..
041204 - [On 091112 0930 Doctor Johnson cited the letter to the
041205 - medical team presenting an agenda for meeting at Kaiser
041206 - that illustrates comprehensive case management based on
041207 - accurate record of patient history. ref SDS 96 XM9J
041209 - ..
041210 - Today, during the meeting, the doctor requested assistance listing
041211 - Millie's prior treatments to prepare a work up for prescribing
041212 - treatment to recover from the 8th relapse of cancer.
041214 - ..
041215 - Millie's patient history was submitted to UCSF in the letter on 090510
041216 - 1553, with the agenda for the meeting today, ref SDS 75 CN6P, linked
041217 - to the record at Kaiser on 090213 1140; showing a comprehensive
041218 - chronology of Millie's treatments, ref SDS 39 ES7I, and which is
041219 - further summarized in the record on 090121 1017. ref SDS 27 H16M
041221 - ..
041222 - Doctor Rugo did not take a few seconds during the meeting to click the
041223 - link in the letter on 090510 for the list of Millie's treatments. She
041224 - found at the bottom of a stack of papers in the UCSF medical chart a
041225 - prior 7-page work up, which UCSF submitted to Kaiser on starting
041226 - Millie's treatment 2-years ago on 070130; Millie's treatments are
041227 - listed in various places throughout the UCSF 070130 report.
041228 - ref SDS 7 4P9G This took about 20 minutes, and seemed to align with
041229 - Millie's patient history submitted on 090510 to expedite work today.
041232 - ..
041233 - 500 Emails a Day Hectic Schedule Order Emergency Care Dying Patients
041235 - Doctor Rugo has a very hectic schedule. The doctor related getting
041236 - over 500 emails per day. Much of her time requires ordering emergency
041237 - care to save the lives of dying patients. The doctor explained today
041238 - that a hectic schedule makes her time more effective getting cursory
041239 - communications that summarize complexity, without contextual framing
041240 - for time, correlations, implications, and nuance on objectives,
041241 - requirements, and commitments that enable comprehensive care.
041243 - [On 090529 1109 tried summarizing complexity of relevant
041244 - patient history for Doctor Rugo, and submitting analysis
041245 - for comprehensive care to the medical team. ref SDS 87 448K
041247 - ..
041248 - [On 090616 1245 Doctor Rugo was asked if she wants to be
041249 - removed from distribution of the record on Millie's complex
041250 - case management, and she said that the record on Millie's
041251 - care at Kaiser and UCSF should continue being sent to her
041252 - email address, as it has the past 2 years. ref SDS 91 HL6I
041254 - ..
041255 - Correspondence linked to written records enables providers to deliver
041256 - accurate, comprehensive care in time to save lives, time and money.
041257 - Accuracy by definition avoids mistakes and rework that occur when
041258 - critical details "slip through the cracks," noted at Kaiser in Doctor
041259 - Johnson's letter on 090205 1318. ref SDS 35 278T However, accurate,
041260 - comprehensive communication seems overwhelming in the moment, when
041261 - people are pressed for time, and do not have tools and support for
041262 - command and control of the record, as set out in POIMS. ref OF 10 1113
041263 - Previously, Doctor Rugo cited frustrations and risks for patients when
041264 - providers cannot find critical details in the medical chart, reported
041265 - on 080219 1100. ref SDS 9 L18L More recently, the doctor complained
041266 - that small, handheld Treo email technology, adopted for high mobility
041267 - has limited viewing and typing capabilities required to manage records
041268 - on complex patient history. reported on 081017 0021. ref SDS 13 6I6J
041269 - This makes deliberation of comprehensive records for accurate
041270 - understanding of relevant patient history, options, and decisions very
041271 - difficult to accomplish.
041273 - ..
041274 - [On 090514 2346 Millie's letter to the medical team
041275 - provides thorough explanation of issues presented today,
041276 - and actions taken in order to assist Kaiser with a
041277 - difficult decison on ordering Millie's care. ref SDS 79
041278 - WF4R
041280 - ..
041281 - [On 090529 1109 tried summarizing complexity of relevant
041282 - patient history for Doctor Rugo, and submitting analysis
041283 - for comprehensive care to the medical team. ref SDS 87 448K
041286 - ..
041287 - Cancer Treated Chronic Disease Prescribed by Primary Care Physician
041289 - Discussed Doctor Johnson's prescription to treat Millie's cancer as a
041290 - chronic disease beginning on 080829, shown by case study on patient
041291 - history during the meeting at Kaiser on 090213, ref SDS 39 PT3N, and
041292 - in a follow up study on 090325. ref SDS 62 L15M
041294 - ..
041295 - On 090121, Glenna, Doctor Rugo's coordinator for Millie's care at UCSF
041296 - called and requested assistance identifying therapies for treating
041297 - Millie's cancer. ref SDS 27 Y67L On 090325 Doctor Johnson at Kaiser
041298 - requested research on therapies for treating Millie's cancer as a
041299 - chronic disease. ref SDS 62 GO4O On 090326, Millie submitted a list
041300 - of 10 treatments targeted to Millie's patient profile, ref SDS 64
041301 - DW5S, and shown in the record on 090205. ref SDS 33 4R3S
041303 - ..
041304 - Doctor Rugo was encouraged today reporting that UCSF has many
041305 - therapies targeted to cancer for treating Millie's complex patient
041306 - profile listed on 090213. ref SDS 39 AC6G She advised that several
041307 - phase I and phase II studies are very promising solutions for treating
041308 - Millie's cancer as a chronic disease. She explained that Millie's
041309 - patient profile of success surviving many relapses makes her case
041310 - difficult for phase III and IV studies that need patients who are less
041311 - medicated than Millie. This aligns with research on 090204, listing
041312 - treatments targeted to cancer for Millie, ref SDS 33 4R3S, and which
041313 - were submitted to the medical team on 090326 0058. ref SDS 64 DW5S
041315 - ..
041316 - [...below, Doctor Rugo's letter to Doctor Johnson at Kaiser
041317 - confirms UCSF planning to treat Millie's cancer as a chronic
041318 - disease after MPA using phase 1 clinical trial care.
041319 - ref SDS 0 DI63
041321 - ..
041322 - The doctor explained in some detail advantages of several treatments
041323 - she plans to use first that seem most promising for Millie's patient
041324 - profile. She did not have time to submit literature nor provide a
041325 - written list of very complex protocol descriptions. Doctor Rugo's
041326 - comprehensive planning for Millie's care presented today aligns with
041327 - Tara's report, during the meeting at UCSF in the Breast Care Clinic on
041328 - 090312, advising that Doctor Rugo has a number of systemic treatments
041329 - lined up for Millie after completing radiation and hyperthermia.
041330 - ref SDS 53 SS4F Later, on 090312 Millie met with Doctor Hsu and Chris
041331 - who explained that the Radiation Oncology Department has further
041332 - treatments that can treat Millie's recurrent cancer, ref SDS 54 F973,
041333 - including combinations with chemotherapy and vaccines. ref SDS 53 F991
041335 - ..
041336 - Today, the doctor also discussed bevacizumab (Avastin) again as a good
041337 - treatment for Millie's patient profile, discussed with Glenna when she
041338 - called on 090121, ref SDS 27 EV53, and citing Doctor Rugo's letter to
041339 - Kaiser on 061230 planning treatment for Millie with bevacizumab and
041340 - abraxane. ref SDS 6 JP5V Today, Doctor Rugo seemed to indicate
041341 - concerns in 2004 that bevacizumab caused death of patients from
041342 - pulmonary embolism was never fully established by evidence.
041344 - [On 090514 2346 Millie's letter notifies medical team Doctor
041345 - Rugo presents a number of modalities to treat Millie's cancer
041346 - as a chronic disease. ref SDS 79 WF9P
041348 - ..
041349 - [On 090529 1109 Millie asks Doctor Rugo about getting treatment
041350 - with bevacizumab at UCSF, rather than Gemzar, which has
041351 - difficult side effects. ref SDS 87 0M6Q
041353 - ..
041354 - Doctor Rugo feels the MPA protocol, explained below, ref SDS 0 A13N,
041355 - provides the best treatment for Millie to recover from the 8th relapse
041356 - by preventing IBC from spreading to internal organs. She said to
041357 - remind Doctor Johnson that getting started right away is critical for
041358 - preventing spread of cancer, because Millie has had no systemic
041359 - treatment since 090122, when sunitinib was stopped. ref SDS 28 J47F
041361 - ..
041362 - The doctor cited MPA advantages for Millie's patient profile...
041364 - 1. MPA treatment is "targeted" for ER negative patients, as
041365 - shown in the protocol Consent documents received today, per
041366 - below. ref SDS 0 KT6U This fits Millie's patient profile
041367 - of triple negative, including ER, PR, HER2 neu all
041368 - negative, reported by Doctor Johnson on 020321. ref SDS 1
041369 - LA7O More recently on 081119 Millie's status as triple
041370 - negative was confirmed in an updated biopsy. ref SDS 15 UQ5P
041372 - ..
041373 - 2. MPA protocol will have less side effects than cetuximab,
041374 - which Millie tolerated very well in 2007 and 2008. Most
041375 - importantly, avoiding chemotherapy with cyclophosphamide
041376 - and Methotrexate will help avoid problems of low blood
041377 - counts that occurred when cyclophosphamide and Methotrexate
041378 - were added to sunitinib during treatment in December and
041379 - January.
041381 - ..
041382 - Doctor Rugo advised that the MPA study is similar to the sunitinib
041383 - protocol that investigated low dose treatment and in combination with
041384 - cyclophosphamide and Methotrexate, prescribed by Doctor Rugo on
041385 - 081016. ref SDS 12 J38U MPA is also being studied in combination with
041386 - these same drugs shown in the protocol below. ref SDS 0 KU4P Doctor
041387 - Rugo plans to exercise doctor discretion for medical necessity
041388 - treating Millie with MPA alone. She feels this avoids chemotherapy
041389 - side effects, which proved to be a problem for Millie's complex
041390 - patient profile on the sunitinib protocol, reported on 090109.
041391 - ref SDS 20 UF3Q
041393 - [On 090616 1245 Millie received MPA without cyclophosphamide,
041394 - ordered by Doctor Rugo to align with Millie's patient profile.
041395 - ref SDS 91 8G76
041397 - ..
041398 - Doctor Rugo advised that Kaiser will have a challenge supporting
041399 - Doctor Johnson's strategy to use new "targeted" technologies that
041400 - maintain Millie's quality of life with clinical trial agents,
041401 - originally explained at Kaiser on 040318. ref SDS 2 DG4J Doctor Rugo
041402 - seemed discouraged today by difficulties getting prior treatments for
041403 - Millie approved by Kaiser in time to be effective, shown by case study
041404 - on 090213. ref SDS 39 ML4H The doctor commented that Kaiser will
041405 - never support Doctor Johnson's numerous orders for UCSF to treat
041406 - Millie's cancer as a "chronic disease" in order to save lives, time,
041407 - and money, reported in case study on 090325 0830. ref SDS 62 L15M
041409 - ..
041410 - [On 090515 0952 Doctor Rugo sent a letter to Millie saying
041411 - UCSF has been notified that Kaiser refuses to continue
041412 - treating Millie with protocols recommended by UCSF to
041413 - recover from the 8th relapse of canser. ref SDS 80 LF3H
041415 - ..
041416 - [On 090515 1017 Millie notifies medical team that Doctor
041417 - Rugo's letter today was received, that Kaiser is
041418 - responsible for Millie's care, and Millie will meet with
041419 - the primary care doctor at Kaiser on 090515 1140 and
041420 - request that Kaiser prescribe care for Millie's 8th relapse
041421 - of cancer based on the best evidence, ref SDS 81 6Q8W, as
041422 - shown in Doctor Rugo's letter to Kaiser on 090514 0830.
041423 - ref SDS 78 DI63
041425 - ..
041426 - [On 090515 1140 Millie met with Doctor Johnson at Kaiser
041427 - and the doctor said that he was told by Doctor Mason that
041428 - the primary care physician, Doctor Johnson, cannot
041429 - prescribe treatment for Millie in a clinical trial, despite
041430 - patient history having prescribed prior clinical trials 4
041431 - times previously, and as a result Doctor Johnson requested
041432 - a draft to assist him preparing an appeal to file with
041433 - Member Services so that Kaiser can expedite Millie's
041434 - recovery from the 8th relapse of cancer. ref SDS 82 655R
041436 - ..
041437 - [On 090515 1518 Doctor Rugo responds wishing Millie "good
041438 - luck." ref SDS 83 EY5L
041440 - ..
041441 - [On 090519 1536 Doctor Johnson changed his mind; he sent
041442 - the draft appeal to Doctor Mason, and tells Millie to file
041443 - an appeal with Member Services, which is incorrect since at
041444 - this time Millie has not been denied medical services; and
041445 - the doctor further says he is suddenly relieved of
041446 - responsibility performed continuously the past 8 years to
041447 - prescribe treatment for Millie to recover from cancer,
041448 - because Kaiser's Outside Referrals Department has a better
041449 - understanding of Medicare. ref SDS 85 5K7H
041451 - ..
041452 - [On 090616 1245 Doctor Rugo advised that "everybody is now
041453 - on board" for Millie's treatment going forward, ref SDS 91
041454 - D647, referring to Millie's proposal on 090518 treating
041455 - "Stage V" patients for long term survival. ref SDS 84 W93Q
041457 - ..
041458 - There was discussion that the first step is for UCSF to submit a
041459 - letter to Doctor Johnson prescribing a protocol based on the best
041460 - evidence for standard of care to treat Millie's patient profile.
041461 - Previously, Doctor Johnson asked UCSF to submit a written plan for
041462 - treating Millie's cancer as a chronic disease. ref SDS 16 V93O This
041463 - provides evidence to Kaiser that justifies ordering treatment in time
041464 - to be effective, since all prior UCSF recommendations for Millie's
041465 - care have been implemented by Kaiser, and have been effective, and
041466 - additionally, Kaiser has requested UCSF's proposal for another
041467 - referral, because Kaiser has no more treatments for Millie's patient
041468 - profile, shown again by case study on 090325. ref SDS 62 L15M
041470 - ..
041471 - Doctor Rugo used the computer in the Examination Room to send a letter
041472 - via email to Doctor Johnson at Kaiser in Walnut Creek recommending MPA
041473 - for Millie's next treatment, per below. ref SDS 0 A13N
041475 - 1. Subject: Millie
041476 - Date: 14 May 2009 10:58:24 -0700
041482 - ..
041483 - 2. Hi, hope you are well.
041485 - ..
041486 - 3. Saw Millie***** today who clearly has progression.
041488 - ..
041489 - 4. She is a candidate for a trial which is ongoing, called
041490 - medroxyprogesterone revisited, out of Indiana, PI Kathy Miller
041491 - for TN disease. We also have a phase I interesting combination
041492 - agent trial opening soon which she could do next.
041494 - [...above, Doctor Rugo explained having many therapies
041495 - targeted to cancer for Millie's patient profile, some are
041496 - phase I and II studies. ref SDS 0 3F7M
041498 - ..
041499 - 5. I am guessing this is all up to authorization - the first is
041500 - oral, so no infusion costs, and the second is IV but phase I so
041501 - infusion costs should be covered. hopefully that makes it
041502 - easier.
041504 - [On 090514 2346 Millie notified the medical team that Doctor
041505 - prescribed a new treatment targeted to Millie's patient
041506 - profile, and implementing Doctor Hsu's treatment plan on
041507 - 090423 for Millie to get systemic treatment to complement
041508 - radiation and hyperthermia treatment UCSF provided on
041509 - referral from Kaiser in February and ending on 090317.
041510 - ref SDS 79 WF9P
041512 - ..
041513 - [On 090515 0952 Doctor Rugo sent a letter to Millie saying
041514 - UCSF has been notified that Kaiser refuses to continue
041515 - treating Millie with protocols recommended by UCSF to
041516 - recover from the 8th relapse of canser. ref SDS 80 LF3H
041518 - ..
041519 - [On 090515 1017 Millie notifies medical team that Doctor
041520 - Rugo's letter today was received, that Kaiser is
041521 - responsible for Millie's care, and Millie will meet with
041522 - the primary care doctor at Kaiser on 090515 1140 and
041523 - request that Kaiser prescribe care for Millie's 8th relapse
041524 - of cancer based on the best evidence, ref SDS 81 6Q8W, as
041525 - shown in Doctor Rugo's letter to Kaiser on 090514 0830.
041526 - ref SDS 78 DI63
041528 - ..
041529 - [On 090515 1140 Doctor Johnson at Kaiser asked for another
041530 - copy of Doctor Rugo's letter on MPA, because he could not
041531 - find the original received from UCSF today. ref SDS 82 0V7L
041533 - ..
041534 - [On 090515 1140 Millie met with Doctor Johnson at Kaiser and
041535 - the doctor said that he was told by Doctor Mason that the
041536 - primary care physician, Doctor Johnson, cannot prescribe
041537 - treatment for Millie with MPA in a clinical trial at UCSF
041538 - despite determining MPA is the best treatment for Millie's
041539 - patient profile to recover from the 8th relapse of cancer,
041540 - and Kaiser has no other treatments suitable for Millie's
041541 - patient profile, and clinical trials are standard of care
041542 - for oncology services, which Kaiser has previously ordered
041543 - for Millie 5 times, and as a result Doctor Johnson requested
041544 - a draft to assist him preparing an appeal to file with
041545 - Member Services so that Kaiser can expedite Millie's
041546 - recovery from the 8th relapse of cancer. ref SDS 82 655R
041548 - ..
041549 - [On 090515 1518 Doctor Rugo responds wishing Millie "good
041550 - luck." ref SDS 83 EY5L
041552 - ..
041553 - [On 090519 1536 Doctor Johnson changed his mind; he sent
041554 - the draft appeal to Doctor Mason, and tells Millie to file
041555 - an appeal with Member Services, which is incorrect since at
041556 - this time Millie has not been denied medical services; and
041557 - the doctor further says he is suddenly relieved of
041558 - responsibility performed continuously the past 8 years to
041559 - prescribe treatment for Millie to recover from cancer,
041560 - because Kaiser's Outside Referrals Department has a better
041561 - understanding of Medicare. ref SDS 85 5K7H
041563 - ..
041564 - [On 090521 0211 Millie's letter to Doctor Rugo with copy to
041565 - Doctor Hsu at UCSF asks if hyperthermia and Doxil can treat
041566 - Millie for 8th relapse of cancer until Kaiser resolves
041567 - delays authorizing treatment with MPA prescribed by Doctor
041568 - Rugo as the best course of care for Millie to recover from
041569 - 8th relapse of cancer. ref SDS 86 FM6R
041571 - ..
041572 - [On 090529 1109 Millie asks Doctor Rugo for the cost to
041573 - participate in the MPA clinical trial at UCSF. ref SDS 87
041574 - 0M6Y
041576 - ..
041577 - [On 090609 0900 Doctor Hsu diagnosed Millie's bleeding sore
041578 - in the breastbone area as progression of cancer because of a
041579 - mistake failing to treat IBC in this area with radiation
041580 - during Feb-Mar, and this untreated cancer in the breastbone
041581 - area caused cancer to spread to other areas, including the
041582 - lungs, which are causing Millie's breathing problems,
041583 - ref SDS 90 W65W; Doctor Hsu prescribed treatment with MPA
041584 - under Doctor Rugo's care in the Breast Care Clinic as the
041585 - UCSF work plan for Millie to recover from medical mistake
041586 - disclosed on 090609. ref SDS 90 W66W
041588 - ..
041589 - [On 090616 1245 Doctor Rugo advised that "everybody is now
041590 - on board" for Millie's treatment going forward, ref SDS 91
041591 - D647, referring to Millie's proposal on 090518 treating
041592 - "Stage V" patients for long term survival. ref SDS 84 W93Q
041594 - ..
041595 - 6. Millie has the consent for the first study. Mike could send
041596 - you whatever you woudl need as well, cc'd above.
041598 - ..
041599 - 7. thanks!
MPA Consent Documents Dated 090325 Treat Mllie's 8th Relapse Cancer
190401 - ..
190402 - MPA Consent Documents Treat Millie's 8th Relapse Cancer
190405 - Doctor Rugo introduced Mike, who is the coordinator for the MPA study
190406 - she recommends for treating Millie's cancer as a chronic disease, and
190407 - to recover from the 8th relapse.
190409 - ..
190410 - Mike came into the meeting for the last 5 minutes.
190412 - ..
190413 - After the meeting, Mike submitted the consent documents for MPA, and
190414 - with the following transmittal letter...
190416 - UCSF Helen Diller Family Comprehensive Cancer Center
190417 - 1600 Divisadero Street, B-612
190418 - San Francisco, CA 94115
190419 - Tel: (415) 885-3789 | Fax: (415) 353-9651
190421 - ..
190422 - May 14, 2009
190424 - ..
190430 - ..
190431 - Subject: UCSF MPA Study
190433 - ..
190434 - Hi Millie,
190436 - ..
190437 - It was lovely to meet you and your husband this morning. As
190438 - discussed, please find attached the consent form for the MPA
190439 - trial. Let me know if you have any questions.
190441 - [On 090601 0818 Millie's letter to UCSF confirming
190442 - arrangements for Millie to get treatment to recover from 8th
190443 - relapse of cancer. ref SDS 88 6Y4U
190453 - ..
190454 - Mike submitted a blue 8.5 x 11 folder, with his business card. Inside
190455 - the folder were consent documents for the MPA study, ref OF 1 0001,
190456 - and dated 090325, shown at the bottom of the form on page 9 of 9,
190457 - ref OF 1 05ZX, and as further shown below. ref SDS 0 K14Y, on Doctor
190458 - Rugo's proposal to Kaiser for treating Millie's 8th relapse of IBC.
190459 - Millie will submit to Doctor Johnson tomorrow at Kaiser for approval
190460 - implementing Doctor Johnson's strategy to treat Millie's cancer at
190461 - UCSF as a chronic disease.
190463 - ..
190464 - [On 090514 2346 Millie notified the medical team that Doctor
190465 - Rugo prescribed a new treatment targeted to Millie's patient
190466 - profile, and implementing Doctor Hsu's treatment plan on
190467 - 090423 for Millie to get systemic treatment to complement
190468 - radiation and hyperthermia treatment UCSF provided on
190469 - referral from Kaiser in February and ending on 090317.
190470 - ref SDS 79 WF9P
190472 - ..
190473 - [On 090601 0818 Millie's letter to UCSF confirming
190474 - arrangements for Millie to get treatment to recover from 8th
190475 - relapse of cancer. ref SDS 88 6Y4U
190477 - ..
190478 - MPA consent document says...
190480 - 1. UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
190481 - CONSENT TO PARTICIPATE IN A RESEARCH STUDY
190483 - ..
190484 - 2. Study Title: MPA [Medroxyprogesterone Acetate] Revisited: A
190485 - Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in
190486 - Postmenopausal Patients with Hormone Receptor Negative Breast
190487 - Cancer, ref OF 1 0001
190489 - ..
190490 - 3. This is a clinical trial, a type of research study. Your study
190491 - doctor(s), Hope Rugo, MD and her associates at the University
190492 - of California, San Francisco (UCSF) Medical Center and
190493 - UCSF/Mount Zion Cancer Center will explain the clinical trial
190494 - to you. ref OF 1 W143
190496 - ..
190497 - 4. Clinical trials include only people who choose to take part.
190498 - Please take your time to make your decision about
190499 - participating. You may discuss your decision with your family
190500 - and friends and with your health care team. If you have any
190501 - questions, you may ask your study doctor. ref OF 1 W144
190503 - ..
190504 - 5. You are being asked to take part in this study because you have
190505 - breast cancer that has recurred or spread to other parts of the
190506 - body. ref OF 1 OH5K
190508 - ..
190509 - 6. Why is this study being done? ref OF 1 W156
190511 - The purpose of this study is to determine if
190512 - medroxyprogesterone acetate (abbreviated MPA) is an effective
190513 - treatment for estrogen receptor negative (ER-) breast cancer.
190514 - MPA has been used in the past to treat ER+ breast cancer.
190515 - Based on recent laboratory studies, we think MPA alone or in
190516 - combinations with low dose oral chemotherapy might be an
190517 - effective treatment for ER- breast cancers as well. This study
190518 - will determine if this is true. ref OF 1 W156
190520 - ..
190521 - 7. This study is funded by UCSF through the Translational Breast
190522 - Cancer Research Consortium. The study sponsor is Indiana
190523 - University. ref OF 1 B46N
190525 - ..
190526 - 8. How many people will take part in this study? ref OF 1 W168
190528 - Between 30 and 50 people will take part in this study,
190529 - including about 5 patients from UCSF. The first 15-25
190530 - patients will be treated with MPA alone. A second group of
190531 - 15-25 patients will be treated with MPA plus low dose oral
190532 - chemotherapy using two drugs called cyclophosphamide and
190533 - methotrexate. ref OF 1 W168
190535 - ..
190536 - 9. What will happen if I take part in this research study?
190537 - ref OF 1 W17K
190539 - ..
190540 - 10. BEFORE YOU BEGIN THE STUDY, ref OF 1 5Q7K
190542 - ..
190543 - 11. You will need to have the following exams, tests or procedures
190544 - to find out if you can be in the study. These exams, tests or
190545 - procedures are part of regular cancer care and may be done even
190546 - if you do not join the study. If you have had some of them
190547 - recently, they may not need to be repeated. This will be up to
190548 - your doctor. ref OF 1 5Q7K
190550 - 1. History and physical examination, ref OF 1 5Q7K
190552 - ..
190553 - 2. Height and weight, ref OF 1 FC8U
190555 - ..
190556 - 3. Performance status (an overall assessment of the impact
190557 - your breast cancer and other factors have on your daily
190558 - life), ref OF 1 FC8W
190560 - ..
190561 - 4. Laboratory testing of blood, ref OF 1 FC9P
190563 - ..
190564 - 5. X-rays or CT scans to evaluate your breast cancer,
190565 - ref OF 1 FC9R
190567 - ..
190568 - 12. IF YOU AGREE AND PROVIDE INFORMED CONSENT, SOME OF THE TISSUE
190569 - THAT WAS COLLECTED FROM YOUR ORIGINAL BREAST CANCER DIAGNOSIS
190570 - WILL BE RETAINED FOR FUTURE RESEARCH. A SEPARATE SECTION AT THE
190571 - END OF THIS CONSENT FORM PROVIDES DETAILS ABOUT THIS OPTIONAL
190572 - PART OF THE STUDY. ref OF 1 H69J
190574 - ..
190575 - 13. DURING THE STUDY, ref OF 1 H64G
190577 - If the exams, tests and procedures show that you can be in the
190578 - study, and you choose to take part, then you will need the
190579 - following tests and procedures. These tests would not be done
190580 - if you were not part of this study. You will not be charged
190581 - for these tests. ref OF 1 H64G
190583 - 1. A skin biopsy, before starting treatment and again after
190584 - you have been on treatment for 4 weeks. The biopsy will be
190585 - taken from an inconspicuous place (most commonly from the
190586 - back of the upper arm) and will be about 4 millimeters, in
190587 - size (about the size of a dime). The skin biopsy is being
190588 - done to evaluate the effect of the study drug. MPA, on
190589 - proteins in the skin. In animals who received MPA, a
190590 - decrease in one of the proteins was associated with a tumor
190591 - response. ref OF 1 H64G
190593 - ..
190594 - 2. Additional blood tests before starting treatment, at week
190595 - 3, week 5, week 9 and every 8 weeks thereafter. ref OF 1
190596 - FC5W
190598 - ..
190599 - 14. The following tests will be done as part of your regular cancer
190600 - care. ref OF 1 VE6Q
190602 - 1. Ongoing physical exams at week 1, week 5, week 9 and every
190603 - 8 weeks thereafter, ref OF 1 VE6Q
190605 - 2. Routine laboratory tests of blood at week 1, week 5, week 9
190606 - and every 8 weeks thereafter, ref OF 1 FC6W
190608 - ..
190609 - 3. Periodic x-rays or CT scans to evaluate your cancer every 8
190610 - weeks, ref OF 1 FD3P
190612 - ..
190613 - 15. If you are assigned "Arm A" - MPA alone, ref OF 1 5S4H
190615 - 1. You will be asked to take MPA by mouth once a day. A blood
190616 - sample will be taken after you have been taking MPA for
190617 - 10-15 days to measure the level of MPA in your blood. If
190618 - this level is too low, you may be asked to take a higher
190619 - dose of MPA each day. ref OF 1 5S4H
190621 - ..
190622 - 2. We will evaluate the effect of the MPA on your tumor with
190623 - x-rays or CT scans after you have been taking MPA for 8
190624 - weeks and then every 8 weeks thereafter. ref OF 1 01PX
190626 - ..
190627 - 16. If you are assigned to "Arm B" - MPA + low dose chemotherapy,
190628 - ref OF 1 9B4H
190630 - 1. You will be asked to take MPA by mouth once a day. A blood
190631 - sample will be taken after you have been taking MPA for
190632 - 10-15 days to measure the level of MPA in your blood. If
190633 - this level is too low, you may be asked to take a higher
190634 - dose of MPA each day. ref OF 1 9B4H
190636 - ..
190637 - 2. You will also be asked to take cyclophosphamide by mouth
190638 - once a day and methotrexate by mouth twice a day for the
190639 - first two days of each week only. We will evaluate the
190640 - effect of the MPA + low dose chemotherapy on your tumor
190641 - with x-rays or CT scans after you have been taking MPA for
190642 - 8 weeks and then every 8 weeks thereafter. ref OF 1 9B53
190644 - ..
190645 - Logistics...
190647 - 1. Study location: All study procedures will be done at the
190648 - UCSF Breast Care Center located at the UCSF Mt Zion Cancer
190649 - Center, ref OF 1 GU6N
190651 - ..
190652 - 2. Blood drawing (venipuncture): At screening and at various
190653 - times throughout your participation in the study a blood
190654 - sample will be drawn by inserting a needle into a vein in
190655 - your arm. ref OF 1 FD5Y
190657 - ..
190658 - 3. X-ray: At screening and at various intervals throughout
190659 - your participation in the study, you may have an x-ray to
190660 - evaluate your cancer. ref OF 1 FD6T
190662 - ..
190663 - 4. CT scan: At screening and at various intervals throughout
190664 - your participation in the study, you may have a computed
190665 - tomography (CT) [/computerized axial tomography (CAT)] scan
190666 - to evaluate your cancer. A CT scan uses special x-ray
190667 - equipment to make detailed pictures of body tissues and
190668 - organs. ref OF 1 FD6Y
190670 - ..
190671 - 5. For the CT scan, you will need to lie still on a table.
190672 - The table will move and the machine will make clicking and
190673 - whirring noises as the pictures are taken. Each CT scan
190674 - will take about 15 minutes to a half hour. ref OF 1 FD7U
190676 - ..
190677 - 17. How long will I be in the study? ref OF 1 FD79
190679 - ..
190680 - You will continue taking the study medication until your tumor
190681 - grows, until unacceptable side effects occur, you withdraw your
190682 - consent, or your doctor thinks you should stop treatment. The
190683 - doctor may stop you from taking part in this study at any time
190684 - if he/she believes it is in your best interest; if you do not
190685 - follow the study rules; or if the study is stopped. ref OF 1
190686 - FD79
190688 - ..
190689 - 18. Can I stop being in the study? ref OF 1 FD89
190691 - ..
190692 - Yes. You can decide to stop at any time. Tell the doctor if
190693 - you are thinking about stopping or decide to stop. He or she
190694 - will tell you how to stop safely. It is important to tell the
190695 - doctor if you are thinking about stopping so any risks from the
190696 - MPA and/or chemotherapy can be evaluated by your doctor.
190697 - Another reason to tell your doctor that you are thinking about
190698 - stopping is to discuss what follow-up care and testing could be
190699 - most helpful for you. The study doctor may stop you from
190700 - taking part in this study at any time if he/she believes it is
190701 - in your best interest, if you do not follow the study rules, or
190702 - if the study is stopped. ref OF 1 FD89
190704 - ..
190705 - 19. What side effects or risks can I expect from being in the
190706 - study? ref OF 1 FD43
190708 - ..
190709 - You may have side effects while on the study. Everyone taking
190710 - part in the study will be watched carefully for any side
190711 - effects. However, doctors don't know all the side effects that
190712 - may happen. Side effects may be mild or very serious. Your
190713 - health care team may give you medicines to help lessen side
190714 - effects. Many side effects go away soon after you stop taking
190715 - the study drugs. In some cases, side effects can be serious,
190716 - long lasting, or may never go away. Death is rare, but
190717 - possible.
190719 - 1. Risks and Side Effects related to MPA include those which
190720 - are:, ref OF 1 01XP
190722 - 1. More likely
190724 - a. Weight gain................... ref OF 1 01XP
190725 - b. Increased appetite............ ref OF 1 01XP
190726 - c. Fluid retention or swelling... ref OF 1 01XP
190728 - ..
190729 - 2. Less likely
190731 - a. Hot flashes
190732 - b. Milky discharge from the breast
190733 - c. Vaginal bleeding or spotting
190734 - d. Nausea
190735 - e. Itching
190736 - f. Rash
190737 - g. Hair thinning
190738 - h. Acne
190739 - i. Hair growth on the chin
190740 - j. Fatigue
190741 - k. Difficulty sleeping
190742 - l. Nervousness
190743 - m. Blood clot in the legs
190744 - n. Headache
190746 - ..
190747 - 3. Rare
190749 - a. Jaundice or yellowing of the skin
190750 - b. Severe allergic reaction
190751 - c. Depression
190752 - d. Dizziness
190753 - e. Blood clot in the lungs............. ref OF 1 0T3V
190755 - ..
190756 - Millie has a history of blood clots in the lungs, and so is being
190757 - treated for pulmonary embolism with Coumadin,
190758 - reported on 041103.
190761 - ..
190762 - 2. Risks and Side Effects related to Cyclophosphamide +
190763 - Methotrexate include those which are
190765 - 1. More likely
190767 - a. Headaches
190768 - b. Nausea, vomiting
190769 - c. Fatigue
190770 - d. Decreased appetite
190771 - e. Diarrhea
190772 - f. Sore mouth or sore throat
190773 - g. Increased appetite
190774 - h. Fluid retention or swelling
190775 - i. Low blood count that could increase risk of infection
190776 - j. Low blood count that could increase risk of bruising or bleeding
190778 - ..
190779 - 2. Less likely
190781 - a. Redness, peeling or tenderness of the hands and feet
190782 - b. Nail changes
190783 - c. Skin rash
190784 - d. Itching
190785 - e. Hair thinning
190786 - f. Headache
190788 - ..
190789 - 3. Rare
190791 - a. Jaundice or yellowing of the skin
190792 - b. Elevated liver function tests which may show possible damage to
190793 - your liver cells
190794 - c. Irritation of the bladder
190796 - ..
190797 - 3. Blood drawing (venipuncture) risks: Drawing blood may
190798 - cause temporary discomfort from the needle stick, bruising,
190799 - and infection.
190801 - ..
190802 - 4. Skin Biopsy
190804 - The risks of having a skin biopsy include pain, bruising,
190805 - bleeding and rarely infection. The skin biopsy may leave a
190806 - scar about the size of a pencil eraser. The skin biopsy
190807 - will be done by your doctor or an experienced nurse. A
190808 - numbing medication will be applied to the skin before the
190809 - biopsy to minimize discomfort. An antibiotic cream will be
190810 - applied after the biopsy to decrease the risk of infection.
190812 - ..
190813 - 5. Radiation (x-ray) risks:
190815 - The amount of radiation you will be exposed to is
190816 - relatively small. Such doses of radiation may be
190817 - potentially harmful, but the risks are so small that they
190818 - are difficult to measure. If you have already had many
190819 - x-rays, you should discuss this with the researchers before
190820 - agreeing to be in the study.
190822 - ..
190823 - 6. CT scan risks:
190825 - CT scans involve the risks of radiation (see above). In
190826 - addition, if contrast material (iodine dye) is used, there
190827 - is a slight risk of developing an allergic reaction, from
190828 - mild (itching, rash) to severe (difficulty breathing,
190829 - shock, or rarely, death). The contrast material may also
190830 - cause kidney problems, especially if you are dehydrated or
190831 - have poor kidney function. The study doctors will ask you
190832 - about any allergies or related conditions before the
190833 - procedure. If you have any of these problems, you may not
190834 - be allowed to have a CT scan.
190836 - ..
190837 - Having a CT scan may mean some added discomfort for you.
190838 - In particular, you may be bothered by feelings of
190839 - claustrophobia when placed inside the CT scanner, or by
190840 - lying in one position for a long time. If contrast
190841 - material is used, you may feel discomfort when it is
190842 - injected. You may feel warm and flushed and get a metallic
190843 - taste in your mouth. Rarely, the contrast material may
190844 - cause nausea, vomiting or a headache
190846 - ..
190847 - 7. Reproductive Risks:
190849 - MPA, cyclosphosphamide and methotrexate can be harmful to a
190850 - fetus. Only postmenopausal women may participate in this
190851 - study. If at any time during the study you suspect that
190852 - you have become pregnant, please notify the study doctor
190853 - immediately.
190855 - ..
190856 - 8. Unknown Risks:
190858 - The experimental treatments may have side effects that no
190859 - one knows about yet. The researchers will let you know if
190860 - they learn anything that might make you change your mind
190861 - about participating in the study.
190863 - ..
190864 - 9. For more information about risks and side effects, ask your study
190865 - doctor.
190867 - ..
190868 - 20. Are there benefits to taking part in the study?
190870 - ..
190871 - Taking part in this study may or may not make your health
190872 - better. While doctors hope this treatment will be effective
190873 - for your cancer, there is no proof of this yet. The
190874 - information learned in this study could help future cancer
190875 - patients.
190877 - ..
190878 - 21. What other choices do I have if I do not take part in this
190879 - study?
190881 - ..
190882 - Your other choices may include:
190884 - 1. Getting treatment or care for your cancer without
190885 - being in a study.
190886 - 2. Taking part in another study.
190887 - 3. Getting no treatment.
190890 - ..
190891 - 22. Talk to your doctor about your choices before you decide if you
190892 - will take part in this study. You may receive treatment at
190893 - this center even if you decide not to participate in this
190894 - research study. Please talk to your regular doctor about these
190895 - options.
190897 - ..
190898 - 23. Will my medical information be kept private?
190900 - ..
190901 - We will do our best to make sure that the personal information
190902 - in your medical record is kept private. However, we cannot
190903 - guarantee total privacy. Your personal information may be
190904 - given out if required by law. If information from this study
190905 - is published or presented at scientific meetings, your name and
190906 - other personal information will not be used.
190908 - ..
190909 - 24. Organizations that may look at and/or copy your medical records
190910 - for research, quality assurance, and data analysis include:
190912 - 1. UCSF's Committee on Human Research
190914 - 2. The National Cancer Institute (NCI) and other government
190915 - agencies, e.g ., the Food and Drug Administration (FDA),
190916 - involved in keeping research safe for people
190918 - ..
190919 - 3. The sponsor(s) of the study: Indiana University
190921 - ..
190922 - 25. What are the costs of taking part in this study?
190924 - 1. You and/or your health plan/insurance company will need to
190925 - pay for some or all of the costs of treating your cancer in
190926 - this study. Some health plans will not pay these costs for
190927 - taking part in studies. Check with your health
190928 - plan/insurance company to find out what they will pay for.
190929 - Taking part in this study may or may not cost you or your
190930 - insurance company more than the cost of getting regular
190931 - cancer treatment.
190933 - ..
190934 - 2. The sponsor of this study will supply the study drug MPA at
190935 - no cost to you. Costs associated with your care, such as
190936 - laboratory tests, x-rays, scans, clinic visits, other
190937 - medications, and hospitalizations are all considered a part
190938 - of standard care for someone with breast cancer; therefore
190939 - you will be responsible for these costs. Cyclophosphamide
190940 - and methotrexate are commonly used to treat breast cancer
190941 - therefore you will be responsible for the cost of these
190942 - drugs.
190944 - ..
190945 - 3. Certain lab tests or procedures are required for the
190946 - research that are not considered a part of standard care
190947 - for your breast cancer, and the costs for these specified
190948 - tests, will be paid for by the study.
190950 - ..
190951 - 4. For more information on clinical trials and insurance
190952 - coverage, you can visit the National Cancer Institute's Web
190953 - site at...
190955 - http://cancer.gov/clinicaltrials/understanding/insurance-coverage
190957 - ..
190958 - 5. You can print a copy of the "Clinical Trials and Insurance
190959 - Coverage" information from this Web site.
190961 - ..
190962 - 6. Another way to get the information is to call
190963 - 1-800-4-CANCER (1-800-422-6237) and ask them to send you a
190964 - free copy.
190966 - ..
190967 - 26. Will I be paid for taking part in this study?
190969 - ..
190970 - You will not be paid for taking part in this study.
190972 - ..
190973 - 27. What happens if I am injured because I took part in this study?
190975 - 1. It is important that you tell your study doctor, Hope Rugo,
190976 - MD or her associates if you feel that you have been injured
190977 - because of taking part in this study. You can tell the
190978 - doctor in person or call him/her at 415 353-7070.
190980 - ..
190981 - 2. Treatment and Compensation for Injury:
190983 - If you are injured as a result of being in this study,
190984 - treatment will be available. The costs of the treatment
190985 - may be covered by the University of California, depending
190986 - on a number of factors. The University does not normally
190987 - provide any other form of compensation for injury. For
190988 - further information about this, you may call the office of
190989 - the Committee on Human Research at 415- 476-1814.
190991 - ..
190992 - 28. What are my rights if I take part in this study?
190994 - ..
190995 - 29. Taking part in this study is your choice. You may choose either
190996 - to take part or not to take part in the study. If you decide
190997 - to take part in this study, you may leave the study at any
190998 - time. No matter what decision you make, there will be no
190999 - penalty to you and you will not lose any of your regular
191000 - benefits. Leaving the study will not affect your medical care.
191001 - You can still get your medical care from our institution.
191003 - ..
191004 - 30. We will tell you about new information or changes in the study
191005 - that may affect your health or your willingness to continue in
191006 - the study.
191008 - ..
191009 - 31. In the case of injury resulting from this study, you do not
191010 - lose any of your legal rights to seek payment by signing this
191011 - form.
191013 - ..
191014 - 32. Who can answer my questions about the study?
191016 - ..
191017 - 33. You can talk to your study doctor about any questions or
191018 - concerns you have about this study. Contact your study doctor,
191019 - Hope Rugo, MD and her associates at (415) 353-7070.
191021 - ..
191022 - 34. For questions about your rights while taking part in this
191023 - study, call the office of the Committee on Human Research,
191024 - UCSF's Institutional Review Board (a group of people who review
191025 - the research to protect your rights) at 415-476-1814
191027 - ******************************************
191029 - ..
191030 - 35. Please note: This section of the informed consent form is about
191031 - an additional research study that is being done with people who
191032 - are taking part in the main study. You may take part in these
191033 - additional studies if you want to. You can still be a part of
191034 - the main study even if you say "no" to taking part in any of
191035 - these additional studies.
191037 - ..
191038 - 36. You can say "yes" or "no" to following study. Please mark your
191039 - choice for each study.
191041 - ..
191042 - 37. About Using Tissue for Research
191044 - ..
191045 - 38. We would like to collect some of the tissue that was collected
191046 - from your original breast cancer diagnosis for future research.
191047 - If you agree, this tissue will be kept and may be used in
191048 - research to learn more about cancer and other diseases. The
191049 - research that may be done with your tissue will probably not
191050 - help you. It might help people who have cancer and other
191051 - diseases in the future.
191053 - ..
191054 - 39. Reports about the research done with your tissue will not be
191055 - given to you or to your doctor. These reports will not be put
191056 - into your health record. The research will not have an effect
191057 - on your care.
191059 - ..
191060 - 40. Things to Think About
191062 - ..
191063 - 41. The choice to let us keep the leftover tissue for future
191064 - research is up to you. No matter what you decide to do, it
191065 - will not affect your care, and you may still take part in this
191066 - study. Your tissue will be used only for research, and it will
191067 - not be sold. You will not be paid for allowing your leftover
191068 - tissue to be used in research, even though the research done
191069 - with your tissue may help to develop new products in the
191070 - future. Similarly, there will be no cost to you for any tissue
191071 - collected and stored for this study.
191073 - ..
191074 - 42. Sometimes tissue is used for genetic research (about diseases
191075 - that are passed on in families). Even if your tissue is used
191076 - for this kind of research, the results will not be put into
191077 - your health records.
191079 - ..
191080 - 43. The tissue specimens will be stored at the NCI Department of
191081 - Pathology in Bethesda, MD. To protect your privacy, your
191082 - samples and medical information will be labeled (or "coded")
191083 - with your study subject number, not your name. Your study
191084 - doctor and his or her staff will keep the link between your
191085 - subject number and your name. Any patient information linked
191086 - to the code will be maintained in a secure database.
191088 - ..
191089 - 44. Samples will be kept indefinitely or until the specimens have
191090 - been used up. Only the designated NCI pathologist and study
191091 - personnel will have access to the specimens.
191093 - ..
191094 - 45. If you decide now that your tissue can be kept for research,
191095 - you can change your mind at any time. Just contact your study
191096 - doctor via telephone or in writing to let him or her know that
191097 - you do not want us to use your tissue. Then the remaining
191098 - tissue will be destroyed and will no longer be used for
191099 - research.
191101 - ..
191102 - 46. Benefits
191104 - ..
191105 - 47. The benefits of research using tissue include learning more
191106 - about what causes cancer and other diseases, how to prevent
191107 - them, and how to treat them.
191109 - ..
191110 - 48. Risks
191112 - The greatest risk to you is the release of information from
191113 - your health records. We will do our best to make sure that
191114 - your personal information will be kept private. The chance
191115 - that this information will be given to someone else is very
191116 - small.
191118 - ..
191119 - 49. Making Your Choice
191121 - ..
191122 - 50. Please read each sentence below and think about your choice.
191123 - After reading each sentence, put your initials in the "Yes" or
191124 - "No" box. If you have any questions, please talk to your
191125 - doctor or nurse, or call our research review board at IRB's
191126 - phone number.
191128 - ..
191129 - 51. No matter what you decide to do, it will not affect your care.
191131 - ******************************************
191133 - 1. My tissue may be kept for use in research to learn about,
191134 - prevent, or treat cancer.
191136 - ..
191137 - YES NO
191139 - ..
191140 - 2. My tissue may be kept for use in research to learn about,
191141 - prevent or treat other health problems (for example:
191142 - diabetes, Alzheimer's disease, or heart ease).
191144 - ..
191145 - YES NO
191147 - ..
191148 - 3. Someone may contact me in the future to ask me to take part
191149 - in more research.
191151 - ..
191152 - YES NO
191154 - ******************************************
191156 - ..
191157 - 52. CONSENT
191159 - ..
191160 - 53. You have been given copies of this consent form and the
191161 - Experimental Subject's Bill of Rights to keep.
191163 - ..
191164 - 54. You will be asked to sign a separate form authorizing access,
191165 - use, creation, or disclosure of health information about you.
191167 - ..
191168 - 55. PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to
191169 - decline to participate or to withdraw at any point in this
191170 - study without penalty or loss of benefits to which you are
191171 - otherwise entitled.
191173 - ..
191174 - 56. If you wish to participate in this study, you should sign
191175 - below.
191177 - ..
191178 - Date
191181 - ..
191182 - Participant's Signature for Consent
191185 - ..
191186 - Date
191189 - ..
191190 - Person Obtaining Consent
191193 - ..
191194 - Date
191197 - ..
191198 - Signature of Translator (if applicable)
191200 - ..
191201 - 57. 080752 CONSENT FORM
191202 - MARCH 25, 2009
191204 - ..
191205 - 58. PAGE 9 OF 9