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, January 22, 2015 at 8:00 a.m. in the 2nd floor
small Meeting Room, Regional Hospital of Scranton, Scranton, PA 18510.
Date:
January 7, 2015
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 November 20, 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:
IBCSG 24-02
DSMC recommendations
S1207
Everolimus IND safety report
N9831
Addendum 20
Changes reflect merger - Alliance
CALGB 40101
Update 12
Editorial changes- Protocol termination
N0147
Termination of patient follow- up
WCGME-IRB Meeting Agenda
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Administrative Changes:
Protocol #
Editorial:
NSABP B 47
Upcoming closure – reaching accrual goal
E 5508
Update 1 – editorial changes
PACCT 1
Update 10 – editorial changes
Administrative Changes:
2.2 The Wound Institute & Research Center –Dr. M. Moore
Protocol #
Editorial:
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Expand sample size to include any
patient who is PCR positive for MRSA.
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Expand sample size to include any
patient who is PCR positive for MRSA.
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Update to reflect current contact.
Expand sample to include any patient
who is PCR positive for MRSA.
WCGME-IRB Meeting Agenda
Page 2 of 9
Administrative Changes:
ICF page one – first paragraph
Version 1 (V1) reads “The reason you are
being asked to participate in this study is
because there is a high incidence or
occurrence of nasal colonization of MRSA in
patients undergoing renal dialysis.” Version 2
(V2) will read “The reason you are being asked
to participate in this study is because there is a
high incidence or occurrence of nasal
colonization of MRSA in patients.”
ICF page two – answer to 2nd question
V1 reads “Subjects who are undergoing renal
dialysis would sign an informed consent
agreement and then be screened for MRSA
nasal colonization using a nasal culture
specimen obtained by touching both nostrils
with sterile cotton tipped culture swab.”
V2 will read “Subjects will sign and informed
consent agreement and then be screened for
MRSA nasal colonization using a nasal culture
specimen obtained by touching both nostrils
with sterile cotton tipped culture swab.”
ICF page 4 – V1 contact “Dr. Kenneth
Rudolph” change to “Dr. Mark V. White”
Protocol 2.2
V1 reads “the outpatient dialysis population
with a known high incidence of nasal
colonization by MRSA would be assessed
using polymerase chain reaction (PCR)
assays.”
V2 will read “the subject would be assessed
using polymerase chain reaction (PCR)
assays.”
Protocol #
001-2014
The Reduction of
Nasal Colonization of
MRSA Using an
Antimicrobial Clip.
Editorial:
Administrative Changes:
Expand sample size to include any
patient who is PCR positive for MRSA.
Protocol 3.1
V1 reads “ A total of thirty dialysis patients that
are PCR positive for MRSA will undergo
quantitative cultures to determine the range of
colony forming units in asymptomatic
colonization.”
V2 will read “ A total of thirty subjects that are
PCR positive for MRSA will undergo
quantitative cultures to determine the range of
colony forming units in asymptomatic
colonization.”
Protocol 3.4
V1 reads “A physician would recruit subjects
who are undergoing outpatient renal dialysis.
V2 will read “A physician will recruit subjects.”
Protocol 6.3
V1 reads “Kenneth H Rudolph, M.D.
khrudolph@verizon.net”
V2 will read “Mark V White, MD, MPH
Chairman, WCGME IRB
whitemv@thewrightcenter.org
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:
Millennium
C16010
C16040
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
11/4/14
MLN9708 Safety Updates
2013-00863 fu 8-interstitial lung
disease, fever, anemia
2014MPI001014 fu 6 adenocarcinoma
of colon
2014MPI002402 fu 1 MDS, Pneumonia
2014MPI002682 fu 1- cardiac failure
2014MPI002855 fu 1- acute mesenteric
ischemia
2014MPI002902 initial- interstitial lung
disease, fever, anemia
2014TJP01414 fu 2- acute bronchitis
2014TJP014698 initial decreased
appetite
TCI2014A02711 fu 4- angina pectoris
11/5/14
2014MPI001107 fu 1- atrial fibrillation
WCGME-IRB Meeting Agenda
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Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
11/7/14
11/10/14
11/12/14
11/14/14
11/17/14
11/20/14
WCGME-IRB Meeting Agenda
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FU:
Adverse Event / Safety Report:
2014MPI001328 fu 6- seizures
2014MPI002584 fu 2- general physical
health deterioration
2014MPI002586 fu 1- acute
cholecystitis
2014MPI002841 initial- infection
2014MPI002845 initial- UTI,
polyomavirus test positive
2014MPI002853 initial- melena,
haematemesis
2014MPI002871 initial- pneumonia
2014MPI000550 fu 3 –seizures
2014MPI002584 fu3- general physical
health deterioration
2014MPI002705 fu 2- malaise
2014MPI002853 fu1- melena,
haematemesis
2014MPI002907 initial- edema
2014MPI002201 fu 2- influenza,
staphylococcus aureus infection
2013-05262 fu 1-cutaneous eruption
2014MPI000166 fu 2- TIA
2014MPI001932 fu 3- tumor lysis
syndrome
2014MPI002583 fu 1- febrile
neutropenia
2014MPI002662 fu 1- arm phlebitis
2014MPI002916 initial- chest pain
2014MPI002945 initial- pneumonia
2014MPI002950 initial- bilateral
pulmonary embolism
2014TJP014698 fu 1- decreased
appetite
TCI2014A02711 fu 5- angina pectoris
2013MPI000959 fu 1- pulmonary
embolism, pneumonia, febrile
neutropenia
2013MPI001165 fu 2- pneumonia
2014MPI00267 fu 3 respiratory tract
infection, pyrexia
2014MPI002402 fu 2- MDS,
pneumonia
2014MPI002621 fu 2 – arrhythemia
2014MPI002855 fu 1 acute mesenteric
ischemia
2014MPI002964 initial- femoral neck
fracture
2014MPI002965 initial- infectious
pneumopathy
2014MPI003009 initial- cardiac arrest
2014MPI002980 initial- pulmonary
edema
2014MPI002990 initial- basal cell
carcinoma
2014MPI003062 initial- cutaneous
eruption
2013MPI001444 initial- febrile
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
11/21/14
11/24/14
11/26/14
12/1/14
12/3/14
12/4/14
WCGME-IRB Meeting Agenda
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FU:
Adverse Event / Safety Report:
neutropenia
2013MPI001452 fu 3- gout
2014MPI001891 fu 3- urinary retention
2014MPI002012 fu3- parainfluenza
virus 3, febrile illness, confusion
2014MPI002241 fu 2- herpes zoster
2014MPI002574 fu 2- atrial fibrillation
2014MPI002641 fu 1- dehydration
2014MPI002871 fu1 pneumonia
2014MPI002945 fu1 pneumonia
2014MPI003021 initial-heart failure
2014MPI001299 fu 5- malaise
2014MPI001460 fu 1- pneumonia
2014MPI002525 fu 1- acute renal
failure, hypoglycemia
2014MPI003100 initial- COPD
2013MPI001261 fu 1 – atrial flutter
2014MPI001825- initial – urosepsis,
pyelonephritis, thrombocytopenia,
cardiac failure, DVT, hyperthermia
2014MPI002845 fu 1 – UTI
2014TJP014698 fu 2- decreased
appetite2013-03958 fu 4- COPD
2013MPI001443 fu 2- Acute renal
failure, hypotension
2014MPI001107 fu 2 – atrial fib
2014MPI001318 fu 1- coronary artery
thrombosis
2014MPI001349 fu 1- pneumonia
2014MPI002621 fu 3- arrhythmia
2014MPI002980 fu 1- pulmonary
edema
2014MPI003075 initial – general
physical health deterioration
2014MPI003082 initial- pyrexia
2014MPI003125 initial- myocardial
infarction
201302614 fu 2- atrial fib
201305262 fu 2- cutaneous eruption
2014MPI001373 fu 5 – syncope, fall
2014MPI003100 fu 1- COPD
2013MPI000648 fu 2 – hypotension
2013MPI000888 fu 1- C-diff
2014MPI000537 UTI fu2
2014MPI001245 organising pneumonia
2014MPI002845 fu 2 UTI
2014MPI002964 fu 1 femur fracture
2014MPI002980 fu 2 pulmonary
edema
2014MPI003119 initial –herpes foster
2014MPI003138 initial – pneumonia
2013-00516 fu 1 Acute renal failure
2014MPI000772 fu 2- MI
2014MPI001107 fu 3 Atrial fibrillation
2014MPI001825 fu 1 urosepsis, DVT,
cardiac failure, hyperthermia
2014MPI001976 fu 2 idiopathic
Organization
and Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
thrombocytopenic purpura
2014MPI003151 initial – peripheral
atery thrombosis
2014MPI003165 initial -hypercalcemia
2014MPI003166 initial- acute renal
failure
2014MPI003170 initial- pain
IBCSG 24-02
11/13/14
11/19/14
S1207
11/13/14
11/19/14
12/5/14
11/04/14
E1609
11/18/14
11/5/14
NSABP B 47
11/17/14
Tamoxifen
10002560 depression
10002565 uterine adenomyosis
Tamoxifen + Triptorelin
10002562 endometrial polyp
10002572 depression
10002589 uterine fibroids
Everolimus
PHHO2014FR008155- abdominal pain/
encephalopathy
PHHO2014US013821- nodular
regenerative hyperplasia- lung infection
PHHO2014US013821 fu 1
Ipilimumab
21194865 encephalitis
Action letter dated 10/24/14
12/15/14
Trastuzumab
799942- initial – contralateral breast
cancer
Updated Trastuzumab IB version 12
dated October 2013
E5508
12/3/14
Patient # 55890 expired – metastatic
disease
E 1609, E3612
12/18/14
MDX-010
#2432573-ISR- Grade 3
encephalopathy, grade 3 renal/urinary
disorder: neurogenic bladder
E3612,E5103,
E5202, E5204,
E5508
12/18/14
Bevacizumab
# 21498240 FU 1- grade 5 death: NOS
E 4805
12/18/14
VEGF-Trap (aflibercept)# 2806788- grade 3 pancreatitis
5. Full Continuing Review:
1o reviewer is: Mark B. White, MD, MPH Chairman, WCGME-IRB
2o reviewer is: Robert Angeloni
WCGME-IRB Meeting Agenda
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5.1.1 Martin Hyzinski, M. D. NSABP: Protocol No.: B 47 “A Randomized Phase III Trial of Adjuvant Therapy Comparing
Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus
Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or
High-Risk Node-Negative HER2-Low Invasive Breast Cancer” was submitted for full continuing review. The study is not
permanently closed to enrollment and extension with review in one year is requested.
5.1.2 Martin Hyzinski, M. D. ECOG: Protocol E 3612 “A randomized Phase II Trial of Ipilimumab with or without
Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma” was submitted for full continuing review. The
study is not permanently closed to enrollment and extension with review in one year is requested.
5.1.3 Martin Hyzinski, M. D. SWOG: Protocol S1207 “Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating
the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive
and HER2/neu Negative Breast Cancer. E^3 Breast Cancer Study- evaluating everolimus with endocrine therapy” was
submitted for full continuing review. The study is not permanently closed to enrollment and extension with review in one
year is requested.
5.1.4 Sonia Planey, PhD. Protocol TCMC02182013SP “ Validation of APF as Urinary Biomarker for Interstitial Cystitis”
was submitted for full continuing review. The study is not permanently closed to enrollment and extension with review in
one year is requested.
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. IBCSG: Protocol No.: 24-02 Pharma Analysis. Study Title: “Cognitive Function
Substudy ANZ 0701 (Co-SOFT)” 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. NSABP: Protocol No.: B 36 “A Clinical Trial of Adjuvant Therapy Comparing Six
Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and
Cyclophosphamide (AC) in Patients With 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. CALGB: Protocol No.: C 9344 “Doxorubicin Dose Escalation, With or Without
Taxol, as Part of the CA Adjuvant Chemo Regimen for Node Positive Breast Cancer:A Ph.III Intergroup Study”
was submitted for expedited continuing review. The study is permanently closed to enrollment but following
patients. Extension with review in one year is requested.
6.1.4 Martin Hyzinski, M. D. ECOG: Protocol No. E 1496 “Randomized Phase III Study in Low Grade
Lymphoma Comparing Maintenance Anti-CD20 Antibody versus Observation Following Induction Therapy”
was submitted for expedited continuing review. The Study is permanently closed to enrollment but following
patients. Extension with review in one year is requested.
6.1.5 Martin Hyzinski, M. D. ECOG: Protocol E2197 “Phase III Study of Adriamycin/Taxotere vs.
Adriamycin/Cytoxan in the Adjuvant Treatment of Node Positive and 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 is requested.
6.1.6 Martin Hyzinski, M. D. ECOG: Protocol No: E2805 “ASSURE: Adjuvant Sorafenib or Sunitinib for
Unfavorable Renal Carcinoma” was submitted for expedited continuing review. The study is permanently
closed to enrollment but following patients. Extension with review in one year is requested.
6.1.7 Martin Hyzinski, M. D. ECOG: Protocol No.: E 5204 “Intergroup Randomized Phase III Study of
Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and
Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation” was
submitted for expedited continuing review. The study is permanently closed to enrollment but following
patients. Extension with review in one year is requested.
6.1.8 Martin Hyzinski, M. D. GOG: Protocol No.: GOG 0218 “A Phase III Trial of Carboplatin and Paclitaxel
Plus Placebo VersusCarboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC#704865,IND#7921)
Followed by Placebo, Versus Caroboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in
Women with Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or
Fallopian Tube Cancer” was submitted for expedited continuing review. The study is permanently closed to
enrollment but following patients. Extension with review in one year is requested.
WCGME-IRB Meeting Agenda
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6.1.9 Martin Hyzinski, M. D. IBCGS: Protocol No. 24-02 “A Phase III Trial Evaluating the Role of Ovarian
Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with
Endocrine Responsive Breast Cancer” was submitted for expedited continuing review. The study is
permanently closed to enrollment but following patients. Extension with review in one year is requested.
6.1.10 Martin Hyzinski, M. D. ECOG: Protocol No.: PACCT- 1 “Program for the Assessment of Clinical Cancer
Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial” was submitted for
expedited continuing review. The study is permanently closed to enrollment but following patients. Extension
with review in one year is requested.
6.1.11 Martin Hyzinski, M. D. SWOG: Protocol No.: S0221 “Phase III Trial of Continuous Schedule AC + G
vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as
Post-Operative Adjuvant Therapy in Node-Positive 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 is requested.
6.1.3. William Heim, M.D. Protocol No. ECOG EST 4494: “A Phase III Trial of CHOP versus CHOP and
Chimeric Anti-CD20 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.
6.2 Protocols Terminated/Final Combination Reports
6.2.1 Martin Hyzinski, M. D. CALGB Protocol 40101 “Cyclophosphamide and Doxorubicin (CA x 4 Cycles)
Versus Paclitaxel (4 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary
Lymph Nodes: A Phase III Randomized Study” was submitted as a final report. No further review is
necessary.
6.2.2 Martin Hyzinski, M. D. CALGB: Protocol 70604 “A Randomized, Phase III Study of Standard Dosing
Versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer” was submitted as a final report. No
further review is necessary.
6.2.3 Martin Hyzinski, M. D. NSABP: Protocol No.: B 44-I “BETH Study: Treatment of HER2 Positive Breast
Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab”
was submitted as a final report. No further review is necessary.
6.2.4 Martin Hyzinski, M. D. NCCTG: Protocol N 0147 “A Randomized Phase III Trial of Oxaliplatin (OXAL)
Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) After Curative Resection for
Patients with Stage III Colon Cancer” was submitted as a final report. The study is closed to follow-up. No
further review is necessary.
6.2.5 William Heim, M. D. ECOG: Protocol E1996 “Phase III Evaluation of EPO With or Without G-CSF versus
Supportive Therapy Alone in the Treatment of Myelodysplastic Syndromes” was submitted as a final report.
The study is closed to follow-up. No further review is necessary. A separate report indicating death of one of
the subjects followed related to progressive disease is on file.
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 Dipti Pancholy, M. D. “To study the current trends and best practices in transition of care among hospitalized patients
and develop measures to improve them to provide better patient care; A prospective observational study-Phase 2 ” was reviewed
and approved by Mark. V. White, M. D. on November 12, 2014. This one year study was approved for one year and must receive
continuing review by November 11, 2015 in order to be continued. The study has been assigned the number
WCGME11122014DP.
6.3.2 Janet Townsend, M. D .“Assessment of TCMC Graduate Preparedness for Residency Training” was reviewed and
approved by Robert H. Angeloni, Co-Chairman on December 9, 2014. This one year study was approved for one year and must
receive continuing review by December 8, 2015 in order to be continued. The study has been assigned the number
TCMC11202014JT.
WCGME-IRB Meeting Agenda
Page 8 of 9
6.3.3 Shalane Vitris, ESU Student “Assessing the Utility of a Web Portal in Garnering Interest in the Dual MD/MPH
Degree Program: Medical Students’ Perceptions” was reviewed and approved by Robert H. Angeloni, Co-Chairman on
December 10, 2014. This one year study was approved for one year and must receive continuing review by December 9,
2015 in order to be continued. The study has been assigned the number ESU09182014SV.
6.3.4 Tiffany Jasulski, Senior MEDENT Specialist, The Wright Center “Emergency Room Care Coordination with the
Primary Care for all Asthma Patients and Adults with an Admitting Diagnosis of Chest Pain” was reviewed and approved by
Mark. V. White, M. D. on December 23, 2014. This one year study was approved for one year and must receive continuing review
by December 22, 2015 in order to be continued. The study has been assigned the number WCGME12152014JT.
6.3.5 Brian Cebulko, PGY-1 Pharmacy Resident-Pharmacist “Prevalence of Early Onset Neonatal Group B Streptococcus
Infection Following Standard Intrapartum Vancomycin Prophylaxis” was reviewed and approved by Mark. V. White, M. D. on
November 10, 2014. This one year study was approved for one year and must receive continuing review by November 9, 2015 in
order to be continued. The study has been assigned the number WU10172014BC.
7. New / Full Review:
None submitted for this month
8. Other Business:
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
Page 9 of 9
Materials Due By:
10 August 2015
03 September 2015
28 September 2015
26 October 2015