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:
November 3, 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:
S1007 S1207
SWOG Fall 2014 Report of Studies
E5103
Addendum #12
Expedited Review
E7208
Addendum #7
Expedited Review
E3612
Addendum #3
Expedited Review
Ipilimumab Action Letter, dated October
24. 2014
WCGME-IRB Meeting Agenda
November 3, 2014
Page 1 of 10
Protocol #
Editorial:
Administrative Changes:
E1609
Addendum #13
Expedited Review
Ipilimumab Action Letter, dated October
24. 2014
NSABP B-43
Memorandum dated October 24, 2014:
Central HER2 Testing to Resume
NSABP FB-5
Memorandum: Study permanently
closed to all follow up as of September
30, 2014
3. Amendments requiring full board review and approval:
None presented for this month.
4.
Adverse Drug Reactions – IND Safety Reports:
4.1.
Scranton Hematology Oncology
Organization
and Protocol
Number:
E1305 E3612
E5103 E5202
E5204 E5508
GOG 0218
GOG 0252
E1609 E3612
Patient
Identifier:
Date:
Initial:
10/08/2014
FU:
Adverse Event / Safety Report:
Bevacizumab Safety Updates:
2278957 Gr. 5 hypomagnesemia
10/22/2014
2149824 Gr. 5 death, NOS
10/08/2014
MDX-010 Safety Updates:
2485819 Gr. 5 Colonic perforation
1265130 fu1 Gr. 4 Blood and
lymphatic system disorders:
WCGME-IRB Meeting Agenda
November 3, 2014
Page 2 of 10
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
Hypercellular marrow
2705907 fu1 Gr. 3 Blood and
lymphatics: Idiopathic
thrombocytopenic purpura (SAE
report reads thrombotic
thrombocytopenic purpura)
2485819 fu1 Gr. 5 colonic
perforation
NSABP B-43, B47
10/22/2014
2485819 fu1 Gr. 5 colonic
perforation
10/06/2014
Trastuzumab Safety Updates:
1454583 fu1 Gastroenteritis
secondary to chemotherapy
Millennium
C16010 and
C16040
10/02/2014
MLN9708 Safety Updates:
2014MPI001891 fu2 Urinary
retention
2014MPI002058 fu1
Hypomagnesemia, hypocalcemia
2014MPI002126 fu1 Fall,
esophageal ulcer
2014MPI002246 fu1 paroxysmal
atrial fibrillation
2014MPI002584 fu1 General
alteration state
2014MPI002610 Other serious
criteria: medically significant,
leucopenia
2014MPI002612 Other serious
criteria: medically significant,
WCGME-IRB Meeting Agenda
November 3, 2014
Page 3 of 10
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
sensory neuropatia
2014MPI002621 Infection
2014MPI002628 Hypokalemia
10/08/2014
2014MPI000426 fu2 Other
serious criteria: medically
significant, dyspnea, hepatic
failure, disease progression
related to esophageal cancer
2014MPI001032 fu5 Lung
infection, thromboembolic event,
dehydration
2014MPI001492 fu3 Chronic
atrophic gastritis
2014MPI002102 fu1 Other
serious criteria: medically
significant, acute respiratory
distress syndrome, dehydration,
nausea
2014MPI002271 fu1 Increased
creatinine, hypotension, confusion
2014MPI002574 fu1
Hypokalemia, atrial fibrillation
2014MPI002641 Dehydration
2014TJP013442 Herpes zoster
10/09/2014
2014MPI000019 Creatinine
increased G3, poor oral intake,
back pain
2014MPI000129 fu8 Other
serious criteria: medically
significant, allergic reaction to
lenalidomide
WCGME-IRB Meeting Agenda
November 3, 2014
Page 4 of 10
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
2014MPI000130 fu2 Other
serious criteria: medically
significant, upper respiratory
infection
2014MPI002596 fu1 Other
serious criteria: medically
significant, septic shock
2014MPI002621 fu1 Arrhythmia
2014MPI002662 Phlebitis
2014MPI002682 Dyspnoea
10/15/2014
2012-02891 fu6 Dehydration,
diarrhea, infection of known
metastases to rectum
2014MPI000019 fu1 Back pain,
creatinine increased G3, poor oral
intake
2014MPI002012 fu2
Parainfluenza virus 3, febrile
illness with hospitalization,
confusion with hospitalization
2014MPI002355 fu1 Arrhythmia
worsening
2014MPI002693 Nose bleed
2014MPI002705 Malaise
2014MPI002713 Death cause
unknown
2014TJP008873 fu4 Deep vein
thrombosis of legs
2014TJP013442 fu1 Herpes
zoster
TCI2014A02711 fu3 Stable
angina pectoris
WCGME-IRB Meeting Agenda
November 3, 2014
Page 5 of 10
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
10/16/2014
FU:
Adverse Event / Safety Report:
2013-01143 fu6 Other serious
criteria: medically significant,
hyponatremia, fracture of the
femur
2014MPI000129 fu9 Other
serious criteria: medically
significant, allergic reaction to
lenolidomide
2014MPI001080 fu1 Other
serious criteria: medically
significant, septic shock
2014MPI001328 fu5 Other
serious criteria: medically
significant, seizures
2014MPI001841 fu1 Neutropenic
fever (Max 38.7 C)
2014MPI001848 fu1 Pneumoniae
in the context of febrile
neutropenia
2014MPI002596 fu2 Other
serious criteria: medically
significant, septic shock
2014MPI002729 Fracture of the
neck of the femur
2014TJP014014 Acute bronchitis
10/20/2014
2014MPI002355 fu2 Arrhythmia
worsening
2014MPI002693 fu1 Epistaxis
2014MPI002762 Dehydration,
diarrhea, infection of known
metastases to rectum
2014TJP013442 fu2 Herpes
WCGME-IRB Meeting Agenda
November 3, 2014
Page 6 of 10
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
zoster
10/22/2014
2014MPI001080 fu2 Other
serious criteria: medically
significant, septic shock
2014MPI001595 fu2 febrile
neutropenia
2014MPI001932 fu1 Tumor lysis
syndrome
2014MPI002102 fu2 Other
serious criteria: medically
significant, acute respiratory
distress syndrome, dehydration,
nausea
2014MPI002267 fu2 respiratory
infection suspected, fever
2014MPI002628 fu1 Hypokalemia
2014MPI002713 fu1 Disease
progression
2014MPI002766 Weakness
2014MPI002783 Other serious
criteria: medically significant,
hyponatremia, fracture of the
femur
2014TJP014014 fu1 Acute
bronchitis
10/24/2014
2014MPI001252 fu4 Other
serious criteria: medically
significant, Pseudomonas
septicemia
2014MPI001932 fu2 Tumor lysis
syndrome
WCGME-IRB Meeting Agenda
November 3, 2014
Page 7 of 10
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
2014MPI002355 fu3 Arrhythmia
worsening
2014MPI002705 fu1 malaise
2014MPI002729 fu1 Fracture of
femoral neck
2014MPI002791 Possible ear
infection
E2805
10/22/2014
Sorafenib Safety Updates:
2306772 Gr. 5 hepatic failure
2306772 fu1 Gr. 5 hepatic failure
Dendreon P10-3
10/27/2014
Sipuleucel-T Safety Updates:
201SIPUSA00013 fu4 Acute
myocardial infarction,
cerebrovascular accident
5. Full Continuing Review:
1o reviewer is: Mark B. White, MD, MPH Chairman, WCGME-IRB
2o reviewer is: Robert Angeloni
None submitted for 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 William Heim, M.D. Protocol No.: JMA 17R. Study Title: “A Phase III Randomized Double Blind Study of
Letrozole vs. Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant
Tamoxifen” 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. William Heim, M.D.: ECOG Protocol N9831 “Phase III Traial of Doxorubicin and Cytoxan Followed by
Weekly Taxol With and Without Herceptin as Adjuvant Treatment for Women With HER2 (+), Noce (+) 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.
WCGME-IRB Meeting Agenda
November 3, 2014
Page 8 of 10
6.1.3. William Heim, M.D. Protocol No. ECOG E1199: “A Phase III Study of Doxorubicin-Cyclophosphamide
Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary NodePosivite or High Risk 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.
6.2 Protocols Terminated/Final Combination Reports
None submitted for this month
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 Karen E. Arscott, D. O., M. Sc.: “ An Interprofessional Collaboration of Simulated Experience for
Students in Nursing, Medicine, and Social Work: was reviewed and approved by Mark V. White, M. D. on
October 15, 2014. This study is approved for one year and must receive continuing review by October
14, 2015 in order to be continued. The study has been assigned the number TCMC09262014KA.
6.3.2 Samuel Lesko, M.D., M. P. H. “Analysis of Breast Cancer Treatment at a Single Hospital in
Scranton, PA” was reviewed and approved by Mark V. White, M. D. on October 17, 2014. The study is
Approved for one year and must receive continuing review by October 16, 2015 in order to be continued.
The study has been assigned the number NRCIBrCa2014.
6.3.3
7. New / Full Review:
7.1 TCMC10282914JH: “ Cancer Prevention Studying an Italian Mutation in BRCA 1”
Protocol Version 1.0 dated September, 2014. Dr. Jeffrey Holt is presenting as Principal Investigator for
The Commonwealth Medical College, Scranton, PA.
1o reviewer is: Paula Roe-Prior, PhD, RN
2o reviewer is: Daniel J. West, PhD
8. Other Business:
8.1
8.2
CITI Training update
Revised 2015 Meeting/submission dates as outlined in agenda item #9.
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
25 June 2015
Materials Due By:
29 December, 2014
02 February 2015
02 March 2015
30 March 2015
30 April 2015
1 June 2015
IRB Meeting Date:
July – Recess
27 August 2015
24 September 2015
22 October 2015
19 November 2015
December – Recess
WCGME-IRB Meeting Agenda
Materials Due By:
10 August 2015
03 September 2015
28 September 2015
26 October 2015
November 3, 2014
Page 9 of 10
WCGME-IRB Meeting Agenda
November 3, 2014
Page 10 of 10