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:
February 6, 2015
Amended February 11, 2015 Section 6.2: Protocols Terminated/Final Combination Reports
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 January 22, 2015 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 #
E5202
Editorial:
Update #6 editorial changes
Study is closed, all patients are in foll
ow up
Expedited review
S1207
Revision #3
Expedited review
IBCSG 24-02
Investigator Letter
Patient Letter
S1007
Revision 9- editorial changes
Expedited review
E 1305
Addendum #13
Editorial changes
WCGME-IRB Meeting Agenda
Page 1 of 9
Administrative Changes:
Protocol #
Editorial:
Administrative Changes:
Updated ICF
Expedited review permitted
Study Closure effective 2/11/15
E 5103
Addendum # 13
Editorial changes
ICF changes
Expedited Review permitted
E7208
Addendum # 8
Full board review
E 2607
Addendum # 13
Editorial changes
ICF changes
Expedited review permitted
Millennium C16014
End of trial. Study closing at site
effective 03Feb2015
NSABP B 47
Impending study closure – estimated
closure during the second week in
February
Study closure February 10, 2015
3. Amendments requiring full board review and approval:
Martin Hyzinski, M. D.
3.1.
E7208, 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.
Addendum #8 dated 1216/2014 with changed to the protocol and informed consent with activation date of
February 11, 2015 as specified by ECOG-ACIRN Operations Office. Full IRB review is required and all subjects
must be re-consented. Full documentation has been provided for member review on the IRB web page.
WCGME-IRB Meeting Agenda
Page 2 of 9
4.
Adverse Drug Reactions – IND Safety Reports:
4.1.
Scranton Hematology Oncology
Organization and
Protocol
Number:
Millennium
16010
16014
Patient
Identifier:
Date:
Initial:
12/08/2014
FU:
Adverse Event / Safety Report:
MLN9708 Safety Updates
2014MPI001547 fu 2- sepsis, febrile
neutropenia, rash macula- popular
2014MPI003021 fu 1 – cardiac failure
2014MPI003189 initial -pulmonary
edema
12/10/2014
2013MPI001452 fu 4 gout
2014 fu 4 MI
2014MPI001825 fu 2 urosepsis, DVT,
hyperthermia
2014MPI003062 fu 1 psoriasis
2014MPI003075 fu 1 pancytopenia
2014MPI003180 initial- peripheral
edema
2014MPI003213 initial- back pain, acute
renal failure
2014TJP016426 initial- back pain, acute
renal failure
12/12/2014
2013-03193-fu 5 – pseudomonas
pneumonia
2013-05519 fu 3 – febrile neutropenia,
skin infection, convulsion, ARDS
2014MPI001861 initial- skin infection,
febrile neutropenia, septic shock,
convulsion, ARDS
2014MPI002945 fu 2 pneumonia
2014MPI003090 initial hypokalemia,
facial edema, peripheral edema
2014MPI003200 initial- malaise,
fatigue,pyrexia
2014MPI003237 initial- abdominal
adhesions
2014MPI003238 initial – cardiac failure
2014MPI003241 initial- weakness
2014MPI002201 fu 3 – influenza, staph
infection
12/15/2014
12/17/2014
WCGME-IRB Meeting Agenda
Page 3 of 9
2014MPI002285 fu 1- dehydration,
anemia
2014MPI002355 fu 4 arrhythmia
2014MPI002621 fu 4 atrial flutter
2014MPI002980 fu3 pulmonary edema
2014MPI003021 fu 2- cardiac failure
2014MPI003151 fu 1- peripheral artery
thrombosis, cardiac arrest
2014MPI003189 fu 1 – pulmonary
edema
2014MPI003243 initial- bile duct cancer
2014MPI003262 initial- phlebitis,
pulmonary embolism
2014MPI003286 initial- incision site
Organization and
Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
erythema
12/19/2014
12/22/14
2014MPI001316 initial- second primary
malignancy
2014MPI001328 fu 7 convulsion
2014MPI003090 fu 1 – hypokalemia,
facial edema, peripheral edema
2014MPI003138 fu 1 – pneumonia
2014MPI003306 initial- fall, radius
fracture
2014MPI003316 initial- pulmonary
infection
2014MPI003318 initial – infectious
colitis, gastroenteritis
2014MPI003323 initial- MI, Cardiac
arrest
2014MPI003347 initial – sepsis
2014TJP016426 fu 1 – back pain, acute
renal failure
2014MPI000527 fu 1- acute
polyneuropathy
2014MPI001861 fu 1- skin infection,
febrile neutropenia, septic shock,
convulsion, ARDS
2014MPI002315 initial- pneumonia
2014MPI002596 fu 3- septic shock
2014MPI003100 fu2 COPD
2014MPI003317 initial- hypertensive
crisis
2014MPI003325 initial- sepsis
2014MPI003341 initial- general
weakness
12/26/2014
2014MPI001373 fu7 –syncope, fall
2014MPI002402 fu3 – myelodysplastic
syndrome, pneumonia
2014MPI002945 fu 3 pneumonia
2014MPI003241 fu1 asthenia,
bronchopneumonia, myeloma
progression
2014MPI003331 initial- chest pain
2014MPI003344 initial- diabetic
ketoacidosis, systemic inflammatory
response syndrome, atrial fibrillation,
cellulitis staphylococcal, acute renal
failure
2014MPI003361 initial – pulmonary
embolism
2014MPI003363 initial- bronchitis
2014MPI003381 initial pleural effusion
2014TJP016426 fu2 back pain, acute
renal failure
12/29/2014
2014MPI001316 fu 1 – second primary
malignancy
2014MPI002621 fu5- atrial flutter
2014MPI003021 fu3- cardiac failure
2014MPI003286 fu 1- wound infection,
WCGME-IRB Meeting Agenda
Page 4 of 9
Organization and
Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
squamous cell carcinoma of skin
2014MPI003316 fu1 – bronchitis
2014MPI003318 fu 1- gastroenteritis,
infectious colitis
2014MPI003347 fu 1 – sepsis
2014MPI003394 initial- lung infection
2014MPI003409 initial- MI
2014MPI003436 initial- cerebral
bleeding, thrombocytopenia
12/31/2014
1/2/2015
2014MPI002402 fu4- MDS, pneumonia
2014MPI003180 fu1- peripheral edema
2014MPI003262 fu 1- phlebitis,
pulmonary embolism
2014MPI003317 fu1 – hypertensive
crisis
2014MPI003387 initial – pneumonitis,
neutrophilia
2014MPI00340 7 initial- acute renal
failure
2014MPI003412 initial – rash
2014MPI003415 initial- lymphocyte
count decreased
2014MPI003419 initial- rectal
hemorrhage secondary to
thrombocytopenia, thrombocytopenia
2014TJP017620 initial – pneumonia
2014MPI003306 fu 1- radius fracture, fall
2014MPI003325 fu1 – sepsis, lower
respiratory tract infection
2014MPI003361 fu1 – pulmonary
embolism
2014MPI003409 fu 1- angina
2014MPI002584 fu4 – general physical
health deterioration, diarrhea
2014MPI002621 fu6 – atrial flutter
2014MPI003241 fu2 – weakness,
bronchopneumonia, myeloma
progression
2014MPI003286 fu 2- medically
significant Rt
2014MPI003446 initial – acute renal
failure, mental status change
2014MPI003451 initial- fever
2014MPI003455 initial- pneumonia,
influenza
1/5/2015
2014MPI003316fu2- bronchitis
2014MPI003363 fu1 –bronchitis
2014MPI003381 fu1 – pleural effusion
2014MPI003469 initial – chest pain
2014TJP017620 fu1 – pneumonia
1/7/2015
2013MPI001049 fu 5 –gastroenteritis,
pneumonia
2014MPI002980 fu4 – supraventricular
tachycardia
1/9/2015
WCGME-IRB Meeting Agenda
Page 5 of 9
Organization and
Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
2014MPI002990 fu1- basal cell
carcinoma
2014MPI003151 fu 2- cardiac arrest,
peripheral artery thrombosis
2015MPI000021 – initial- pneumonia
2015MPI000059 initial- Bronchitis, lung
infection
2015MPI000077 initial- febrile
neutropenia
2015MPI000090 initial – multi-organ
failure
1/12/2015
1/14/2015
2014MPI001932 fu4 – tumor lysis
syndrome
2014MPI002621 fu7 – supraventricular
tachycardia
2014MPI002907 fu 1- edema
2014MPI003262 fu 2- phelebitis,
pulmonary embolism
2014MPI003286 fu 3 – medically
significant rt
2014MPI003451 fu1 fever
2014MPI003469 fu 1 – pulmonary
embolism
2014TJP016426 fu3- back pain, acute
renal failure
2014TJP017620 fu 2 – pneumonia
2015MPI000021 fu 1- pneumonia
1/16/2015
2014MPI000200 fu 4dehydration,pulmonary embolism,
metastatic malignant melanoma
2014MPI001316 fu 3- second primary
malignancy
2014MPI001316 fu3 – second primary
Malignancy
2014MPI003341 fu 1- asthenia
2015MPI000096 initial- pyrexia
2015MPI000101 initial- asthenia
1/19/2015
2014MPI003446 fu1 acute renal failure,
mental status changes
2014TJP017620fu3- pneumonia
2014MPI002196 fu2- bronchopulmonary
aspergillosis
2014MPI002285 fu 2- anemia
2014MPI003361 fu2- pulmonary
embolism
2015MPI000101 fu 1- asthenia,
orthostatic hypotension
2015MPI000123 initial- back pain
2015MPI000161 initial- lymphocyte
count decreased
2015MPI000168 initial- cardiac failure
1/21/2015
2014MPI002845 fu 3 –UTI
2014MPI003316 fu3 bronchitis
1/23/2015
WCGME-IRB Meeting Agenda
Page 6 of 9
Organization and
Protocol
Number:
Patient
Identifier:
Date:
Initial:
Adverse Event / Safety Report:
2014MPI000131 initial – febrile
neutropenia, pyrexia
2015MPI000185 initial- general health
deterioration
2015MPI000206 initial- hypotension,
anemia
2015MPI000258 initial- WBC decreased,
neutrophils decreased
1508949 initial- sudden death,
neutropenia, weakness, dehydration,
colitis
2012-02891 fu 7 – dehydration, diarrhea,
anorectal infection
2014MPI002402 fu5 – panycytopenia,
pneumonia
2014MPI002841 fu 1- upper respiratory
tract infection
2014MPI003446 fu 2- acute renal failure,
mental status changes, blood creatinine
increased
2015MPI000216 initial- osteonecrosis of
jaw
2015MPI000281 initial- encephalopathy
1/26/2015
1/28/2015
2014MPI002458 fu 2- pneumonia
2014MPI002621 fu 6 supraventricular
tachycardia
2014MPI002980 fu5 supraventricular
tachycardia
2014MPI003119 fu 1 Herpes zoster
2014MPI003451 fu 2- fever
2014MPI003455 fu 1 pneumonia,
influenza
2015MPI000059 fu1 bronchitis, lung
infection
2015MPI000251 initial –RSV
2015MPI000264 initial dyspnea
2015MPI000267 initial- basal cell
carcinoma
1/30/2015
2014MPI003331 fu –asthma
2015MPI000077 fu1-febrile neutropenia
2015MPI000284 initial – dyspnea
2015MPI000288 initial- abdominal pain
2/2/2015
Dendreon – sipuleucel- T
2013SIPUSA00016 fu 3- metastatic
prostate cancer - death
Dendreon Proceed
S 1207
FU:
Everolimus –
2086422 initial- gastrointestinal
disorders: Dieulafay lesion, gastric
hemorrhage
Cover Memo
PHHO2014FR016631 iridocyclitis
PHHO2014AR004429 brain edema,
cardio- resp arrest, diarrhea,
dehydration, gastric hemorrhage,
1/8/2015
1/22/2015
WCGME-IRB Meeting Agenda
Page 7 of 9
Organization and
Protocol
Number:
Patient
Identifier:
Date:
Initial:
FU:
Adverse Event / Safety Report:
decreased weight, tonic- clonic seizure,
visual acuity decreased, gastroenteritis,
vomiting, TIA
E5508
1/27/2015
Patient # 55966 expired second to
pneumonia.
E1305, E1609,
E 3612, E5103,
E5202,E5204,
E5508
1/28/2015
Bevacizumab
#2630178-ISR- encephalopathy
E1609, E3612
1/28/2015
MDX-010
2953661- hearing impaired
5. Full Continuing Review:
1o reviewer is: Mark B. White, MD, MPH Chairman, WCGME-IRB
2o reviewer is: Robert Angeloni
5.1.1 Chirstopher Dressel, M. D. Protocol JoStent : Jomed Coronary Stent Humanitarian Device Approcal: Jostent
Graftmaster Rx. 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 Michael Moore, M. D. Protocol 001-2014 “Eradication of Nasal Colonization of MRSA Using a Non-Antimicrobial Clip”
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 William Heim, M. D. Protocol C9710 “ Phase III Randomized Study of Concurrent Tretinoin and
Chemotherapy with or without Arsenic Trioxide (As2O3) (NSC # 706363) as Initial Consolidation Therapy
Followed by Maintenance Therapy with Intermittent Tretinoin Therapy Versus Intermittent Tretinoin Plus
Mercaptopurine and Methotrexate for Patients woith untreated Acute Promyelocytic Leukemia” was submitted
for expedited continuing review. The study is permanently closed to enrollment but following patients.
Extension with review in one year is requested.
6.1.2 William Heim, M.D. Protocol No. ECOG/CTSU N0147 “ A Randomized Phase III Trial of Irinotecan and/or
Oxaliplatin Plus 5 FU/Leucovorin with or without Cetuximab after Curative Resection for Patients with Stage III
Colon 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
6.2.1 Michael Moore, M. D. Protocol 2009-1 (Sponsor Army Protocol W81XWH-07-0636) “ Silver Foam
Hemostatic Bandage as an Effective Hemostatic and Antibacterial Agent in the Treatment of Wound Requiring
Secondary/Delayed Closure” was submitted as a final report. No further review is necessary.
6.3 Expedited New Reviews
WCGME-IRB Meeting Agenda
Page 8 of 9
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 Bradley Stoker, D. O. “Identifying Measures of Wellness at a Community Health Center” was reviewed
and approved by Mark V. White, MD, MPH, and Chairman on January 12, 2015. The study is approved for
one year and must receive continuing review by January 11, 1026 to be continued. The study has been
assigned the number Protocol WCGME12012014BS.
6.3.2 Jennifer Malinowski, Pharm D, RPh. “Implementation of Rapid Cycle Processes Developed through
Interprofessional Collaboration to Promote Awareness of Hydrocodone-Containing Combination Product
Prescribing Challenges” was reviewed and approved by Mark V. White, MD, MPH, and Chairman on January
12, 2015. The study is approved for one year and must receive continuing review by January 11, 2016 to be
continued. The study has been assigned the number WU11112014JM.
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