WCGME-IRB
The Wright Center for Graduate Medical Education
Institutional Review Board
Mark V. White, M.D., Chairman
To:

Robert H. Angeloni, MPA, Co-Chairman
Members of the WCGME-IRB
From: Mark V. White, M.D., Chairman WCGME-IRB
Re:
Agenda for the WCGME-IRB meeting on Thursday, October 23, 2014 at 8:00 a.m. in the 2nd floor
small Meeting Room, Regional Hospital of Scranton, Scranton, PA 18510.
Date:
October 10, 2014
Protocols, reports, and items submitted for agenda sections 3, 5, 6 and 7 are available on the WCGME-IRB
web page. Click on the “Institutional Review Board” link on The Wright Center web page
(www.thewrightcenter.org). Click on the Member Resources link and enter the password. You will need a
current version of Adobe Acrobat Reader to view the file.
1. Review of minutes and reports of actions taken:
Review of the September 25, 2014 minutes. Minutes are included on the web page and in the meeting
documentation packet.
2. Addenda/Memoranda/Editorial/Administrative Changes:
2.1.
Scranton Hematology – Oncology
Protocol #
Editorial:
Administrative Changes:
NSABP B-43 B-47
Updated Investigator’s Brochure (IB) for
Herceptin (Trastuzumab), Version 14,
dated October 2013
NSABP B-42
Amendment #6
FULL BOARD REVIEW
Addendum #10
Expedited Review
E1609
Addendum #11
FULL BOARD REVIEW
Addendum #12
WCGME-IRB Meeting Agenda
September 25, 2014
Page 1 of 9
Protocol #
Editorial:
Administrative Changes:
Expedited Review
Updated Ramucirumab Investigator’s
Brochure (IB), Version 11.0, dated 13
May 2014
E7208
3. Amendments requiring full board review and approval:
3.1 Scranton Hematology Oncology
Ammendment #6 for protocol NSABP B-42 “ A Clinical Trial to Determine the Efficacy of Five Years of
Letrozole Compared to Placebo in Patients Receiving Five Years of Hormonal Therapy consisting of
An Aromatase Inhibitor (AI) in Prolonging Disease-Free Survival in Postmenopausal Women with
Hormone Receptor Positive Breast Cancer” requires full board review and approval due to administrative
changes in the Protocol due to the transition to NRG Oncology and NCI-requested changes. There are no
changes to the content of the Optional Registration Program Sample Consent Form or the Main Study Sample
Consent Form. The date of the consent forms has been changed to match the most recent version of the
protocol.
3.2 Amendment #11 for protocol E1609 “A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy
Versus High Dose Interferon a-2b for Resected High-Risk Melamoma requires full board review due to changes in
The Informed Consent to include: Version date on the cover page, change in header from ECGO-ACRIN to
ECOG-ACRIN, update with all mentions of interferon to “interferon alfa-2b” for consistency. Addendum changes
Also include the following changes in the Pediatric Informed Consent/Parental Permission Form: Updated
Version date on the cover page, global changes throughout the consent with named pediatric arms D, E, and F,
Updated all mentions of interferon to “interferon alfa-2b” for consistency, addedto possible side effects of
Ipilimumab Nonsteroidal anti-inflammatory Drugs (NSAIDS) per CTEP recommendation, and Added “will
participate” to the end of the paragraph referencing how many people will take part in the study.
4.
Adverse Drug Reactions – IND Safety Reports:
4.1.
Scranton Hematology Oncology
Organization
and Protocol
Number:
Millennium
C16010 and
C16040
Patient
Identifier:
Date:
Initial:
09/08/2014
FU:
Adverse Event / Safety Report:
MLN9708 Safety Updates:
2014MPI001252 fu3 Other serious
criteria: medically significant,
Pseudomonas septicemia
2014MPI001373 fu4 Collapsesyncopal episode, fall
2014MPI001887 Other serious
criteria: medically significant, heart
failure
WCGME-IRB Meeting Agenda
September 25, 2014
Page 2 of 9
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
2014MPI002241 fu1 Herpes zoster
2014MPI002285 Dehydration
2014MPI002350 Other serious
criteria: medically significant,
Arrhythmia worsening
2014TJP010770 fu2 Bronchitis
2014MPI002201 fu1 Death
2014MPI000137 fu6 Transverse
myelitis
2014MPI001328 fu3 Other serious
criteria: medically significant,
seizures
2014MPI001860 fu1 Pulmonary
infection, mood alteration
2014MPI002355 Arrhythmia
worsening
09/12/2014
2014MPI000608 fu1 Other serious
criteria: medically significant,
pneumonia
2014MPI001032 fu4 Other serious
criteria: medically significant, lung
infection, cardiopulmonary arrest,
multiple myeloma progression,
thromboembolic event, dehydration
2014MPI001828 fu3 Other serious
criteria: medically significant,
adenocarcinoma sigmoid colon
2014MPI001887 fu1 Other serious
criteria: medically significant, heart
failure
2014MPI001976 fu1 Other serious
criteria: medically significant,
idiopathic thrombocytopenic
WCGME-IRB Meeting Agenda
September 25, 2014
Page 3 of 9
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
purpura
2014MPI002419 Other serious
criteria: medically significant,
Alkaline phosphatase- high
2014MPI002445 Worsening pain
2014TJP008873 fu3 Deep vein
thrombosis
09/18/2014
2013MPI000238 fu6 Dyspnea
(etiology unknown)
2013MPI000325 fu4 Atrial
fibrillation, constipation
2014MPI000608 fu2 Other serious
criteria: medically significant,
pneumonitis
2014MPI000916 fu1 Dyspnea
(etiology unknown)
2014MPI001527 Patient deceased,
abdominal pain
2014MPI002458 Pneumonia
2014MPI002458 fu1 Pneumonia
2014MPI002459 Confusion
09/24/2014
2014MPI001328 fu4 Other serious
criteria: medically significant,
seizures
2014MPI001987 fu1 Other serious
criteria: medically significant,
medication error, no adverse event
2014MPI002350 fu1 Other serious
WCGME-IRB Meeting Agenda
September 25, 2014
Page 4 of 9
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
criteria: medically significant,
arrhythmia worsening
2014MPI002402 Other serious
criteria: medically significant,
myelodysplasia
2014MPI002419 fu1 Other serious
criteria: medically significant,
alkaline phosphatase high
2014MPI002525 Other serious
criteria: medically significant, acute
kidney injury, hypoglycemia
2014MPI002574 Hypokalemia,
atrial fibrillation
2014MPI002583 Febrile
neutropenia
09/26/2014
2014MPI001828 fu4 Other serious
criteria: medically significant,
adenocarcinoma sigmoid colon
2014MPI002584 General alteration
state
2014MPI002586 Febrile syndrome
related to bacteremia
2014MPI002596 Other serious
criteria: medically significant, septic
shock
2014TJP006966 fu3 Invasive
brochopulmonary aspergillosis
IBCSG-24-02
09/08/2014
Triptorelin and Tamoxifen Safety
Updates:
10002485 Uterine Leiomyoma
10002498 Deep vein thrombosis
WCGME-IRB Meeting Agenda
September 25, 2014
Page 5 of 9
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
E1609 E3612
FU:
Adverse Event / Safety Report:
MDX-010 Safety Reports:
09/10/2014
2510839 fu1 Gr. 3 Uveitis
09/24/2014
2485819 Gr. 5 Colonic perforation
1265130 fu1 Gr. 4 Blood and
lymphatic system disorders:
hypercellular marrow
2705907 Gr. 3 Blood and
lymphatics: Idiopathic
thrombocytopenic purpura (SAE
report reads thrombotic
thrombocytopenic purpura)
NSABP B-43, B47
09/02/2014
Trastuzumab Safety Updates:
1368748 fu3 Fulminant hepatic
failure, Hepatitis B infection
09/08/2014
1451498 Cardiac arrest
1451583 Dehydration, nausea,
vomiting
NSABP B-44, B46
09/29/2014
Bevacizumab Safety Updates:
2278957 Gr. 4 hypomagnesemia
WCGME-IRB Meeting Agenda
September 25, 2014
Page 6 of 9
Organization
and Protocol
Number:
Patient
Identifier:
Dendreon P10-3
Date:
Initial:
09/17/2014
FU:
Adverse Event / Safety Report:
Provenge (sipuleucel-T)
Suspension Safety Updates:
2013PROUSA02703 Deep vein
thrombosis
S1207
09/22/2014
Everolimus Safety Updates:
PHHO2014JP009849 Hepatic
artery occlusion, cholangitis
PHHO2014ES011418 Other
serious criteria: medically
significant, ascitis, edemas
E1305 E3612
E5103 E5202
E5204 E5508
GOG 0218
GOG 0252
09/24/2014
Bevacizumab Safety Updates:
2278957 Gr. 4 hypomagnesemia
5. Full Continuing Review:
1o reviewer is: Mark B. White, MD, MPH Chairman, WCGME-IRB
2o reviewer is: Robert Angeloni
5.1
None submitted for review this month.
6. Expedited Continuing Review:
1o reviewer is: Mark B. White, MD, MPH Chairman, WCGME-IRB
2o reviewer is: Robert Angeloni
6.1.1 Martin Hyzinski, M.D. Protocol No.: B 35. Study Title: “A Clinical Trial Comparing Anastrozole with
Tamoxifen in Postmenopausal Patients with Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy with
Radiation Therapy” was submitted for expedited continuing review. The study is permanently closed to
enrollment but following patients. Extension with review in one year was requested.
6.1.2. Martin Hyzinski, M.D CALGB 49907 “A Randomized Trial of Adjuvant Chemotherapy with Standard
Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide
– (AC), Versus Capecitabine in Women 65 Years and Older with Node Positive or Node-Negative Breast
Cancer” was submitted for expedited continuing review. The study is permanently closed to enrollment but
following patients. Extension with review in one year was requested.
6.1.3. Martin Hyzinski, M.D. Protocol No.: P 10-3 “PROCEED: A Registry of Sipuleucel-T Therapy in Men
with Advanced Prostate Cancer
WCGME-IRB Meeting Agenda
September 25, 2014
Page 7 of 9
‘ was submitted for expedited continuing review. The study is permanently closed to enrollment but following
patients. Extension with review in one year was requested.
6.1.4. Martin Hyzinski, M.D. Protocol No.: E 1697 ”Phase III Randomized Study of Four Weeks High Dose
IFN-alpha2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (Microscopic) Melanoma” was
submitted for expedited continuing review. The study is permanently closed to enrollment but following
patients. Extension with review in one year was requested.
6.1.5. Martin Hyzinski, M.D. Protocol No.: E 2188. “Phase III Comparison of Adjuvant Chemotherapy with or
Without Endocrine Therapy in High-Risk, Node Negative Breast Cancer Patients” was submitted for expedited
continuing review. The study is permanently closed to enrollment but following patients. Extension with
review in one year was requested.
6.1.6. Martin Hyzinski, M.D. Protocol No.: E 4494.” Phase III Trial of CHOP versus CHOP and Chimeric AntiCD20 Monoclonal Antibody (IDEC-C2B8) in Older Patients with Diffuse Mixed, Diffuse Large Cell and
Immunoblastic Large Cell Histology Non-Hodgkin's Lymphoma” was submitted for expedited continuing
review. The study is permanently closed to enrollment but following patients. Extension with review in one
year was requested.
6.1.7. Martin Hyzinski, M.D. Protocol No.: E 5103. “A Double-Blind Phase III Trial of Doxorubicin and
Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive
and High Risk Lymph Node Negative Breast Cancer” was submitted for expedited continuing review. The
study is permanently closed to enrollment but following patients. Extension with review in one year was
requested.
6.1.8. Martin Hyzinski, M.D. Protocol No.: E 7208. “A Randomized Phase II Study of Irinotecan and Cetuximab
with or Without the Anti-Angiogenic Antibody, Ramucirumab (IMC-1121B), in Advanced, K-ras Wild-Type
Colorectal Cancer Following Progression on Bevacizumab-Containing Chemotherapy” was submitted for
expedited continuing review. The study is permanently closed to enrollment but following patients. Extension
with review in one year was requested.
6.1.9. Martin Hyzinski, M.D. Protocol No.: GOG 0252. “A Phase III Clinical Trial of Bevacizumab with IV
Versus IP Chemotherapy in Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma NCI-Supplied
Agent(s): Bevacizumab (NSC #704865, IND #7921)” was submitted for expedited continuing review. The study
is permanently closed to enrollment but following patients. Extension with review in one year was requested.
6.2 Protocols Terminated/Final Combination Reports
6.2.0. William J. Heim, M. D. Protocol MA.21 “ A Clinical Trial Comparing 3 Combinations of Chemotherapy:
EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus AC Followed by Paclitaxel Versus CEF in
Premenopausal and Early Postmenopausal Woman Who Have Had Surgery for Axillary Node Positive or High
Risk Node Negative Breast Cancer” was submitted as a final report. The study is permanently closed to
enrollment and was submitted as a final report. No further review is necessary.
6.3 Expedited New Reviews
The following expedited reviews were conducted by the Chairman and/or the Co-Chairman. They are
presented for the Board’s information. Complete documentation for these studies is available for inspection by
IRB Members in the WCGME-IRB Administrative office.
6.3.1 Youngjin Cho, PhD “Histological Evaluation of osteoporotic bone for AFAP1 and Src protein expression”.
The study was reviewed and approved by Mark V. White, M. D. on September 18, 2014. This one year study
was approved for one year and must receive continuing review by September 17, 2015 in order to be
continued. The study has been assigned the number TCMC09082014YC.
7. New / Full Review:
7.1
None submitted for review this month
WCGME-IRB Meeting Agenda
September 25, 2014
Page 8 of 9
8. Other Business:
8.1
8.2
Follow-through on remaining open IRB seat
Discussion of draft schedule for IRB reviews; update in IRB member research area(s) of
expertise
9. Dates to Remember:
A twelve month running list of WCGME-IRB meetings
IRB Meeting Date:
22 January 2015
26 February 2015
26 March 2015
23 April 2015
28 May 2015
26 June 2014
Materials Due By:
05 January 2015
09 February 2015
09 March 2015
06 April 2015
11 May 2015
09 June 2014
IRB Meeting Date:
July – Recess
28 August 2014
25 September 2014
23 October 2014
20 November 2014
December – Recess
WCGME-IRB Meeting Agenda
Materials Due By:
11 August 2014
08 September 2014
06 October 2014
03 November 2014
September 25, 2014
Page 9 of 9