Minutes of the I - OSTI.GOV

ARM1.950119.004d

DEPARTMENT OF THE ARMY Fitzsimons Army Medical Center Aurora, Colorado 80045-5001

HSHG-CI 2 March 1993 SUEUECT: Minutes of the Institutional Review Committee Meeting

1. Under the provisions of HSCR 40-23 (Medical Services), Management of Clinical Investigation Protocols and Reports, and AR 70-25, (Research and Development), Use of Volunteers as Subjects of Research, an Institutional Review Committee (IRC) meeting was held on 2 March 1993. The IRC is a single committee which serves the functions of the Clinical Investigation Committee and the Human Use Committee as stipulated in AR 40-38, paragraph 2-7c(3). Agenda and protocols were distributed to the IRC members on 18 Feb 93.

2. Members present: *Kenneth Sherman, MAJ, MC, Chief, Dept of Clinical Investigation

*+Thomas Cosgriff, COL, MC, Chief, Hem/Onc Svc, Dept of Medicine +Margaret Cline, COL, AN, Chief, Nursing Education and Staff

Kenn Roehl, LTC, AR, Executive Officer, U.S.Army Readiness Group

Acting Chairman (Tiebreaker)

Development Service, Department of Nursing

Denver, representing +James Record, COL, FA, Commander, U.S. Army Readiness Group Denver, FAMC Nonaffiliated Member

Department of Clinical Investigation *+Richard Sherman, LTC, MS, Chief, Clinical Biometrics and

Research Design Service, Dept of Clinical Investigation +Theodore Felton, MAJ, MS, Chief, Optical Div, US Army Medical

Equipment and Optical School, FAMC Non-Affiliated Member (absentia)

*William Reed, MAJ, MC, Staff, General Internal Medicine Service

*Steven Neish, MAJ, MC, Cardiology Svc, Department of Pediatrics +John R. Tarr, LTC, MC, Chief, Child-Adolescent Psychiatry

+Anthony Kutsch, CPT, JA, Assistant Judge Advocate *Kathleen Nolte, lLT, MS, Oncology Pharmacist +SGM Marlene Reading, Chief Wardmaster, Department of Nursing Albert Lambert, CPT, MC, Nuclear Medicine Service, representing

*Mike McBiles, MAJ, MC, Nuclear Medicine Service, Dept of Rad +Phillip Wondra, Chief, Geographical Information Systems

Division, National Parks Service, FAMC Nonaffiliated Member

u *Richard Harris, LTC, MS, Chief, Microbiology Service,

Dept of Medicine

Service, Department of Psychiatry

*Clinical Investigation Committee Member +Human Use Committee Member

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HSHG-CI 2 March 1993 SUBJECT: Minutes of the Institutional Review Committee Meeting

3. Members absent: *+Thomas A. Verdon, Jr., COL, MC, Deputy Commander/Deputy

Commander for Clinical Services, Chairman (Tiebreaker) *Steve Larsen, COL, MS, Chief, Department of Pathology +Samuel Adamson, MAJ, CH, Dept of Ministry and Pastoral Care *Richard Kopke, MAJ, MC, Chief, Otolaryngology Svc, Dept of Surg +Mary Woolverton, MSW, ACSW, Exceptional Family Member Service,

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Department of Pediatrics

4. Others present: Craig Donatucci, LTC, MC, Chief, Urology Service James Hasbargen, LTC, MC, Chief, Nephrology Service Edward Lisecki, LTC, MC, Orthopedic Surgery Service Wynona Stephens, LTC, AN, Regional Research Nurse, Department of

Keith Konkol, MAJ, MC, Infectious Disease Service George Maher, MAJ, MC, Pediatric Oncology Service John Hagan, CPT, MC, Resident, Dept. of Medicine Marcia Bilak, DAC, Research Protocol Specialist, DCI S. Kathleen Collins, RN, Clinical Research Associate,

Robin Creager, RN, Clinical Research Associate,

Erin Palestro, RN, DAC, Clinical Research Coordinator - Marilyn Ressman, RN, DAC, Oncology Data Manager

Nursing

Facilitators of Applied Clinical Trials

Facilitators of Applied Clinical Trials

5. MAJ Sherman opened the meeting at 1405 after determining a majority of members were present, including at least one member whose concerns are in nonscientific areas and at least one unaf- filiated member. MAJ Felton submitted absentee votes. There were no objections to the tape recording of the meeting.

6. Old business:

a. The FAMC Command Section approved the minutes of the 2 Feb 93 meeting.

b. Correction to Oct 92 minutes: The annual continuing review of the Pediatric Oncology Group Protocols was performed by the Institutional Review Committee of Fitzsimons Army Medical Center on 6 Oct 92. The minutes contain typographical errors as follows: 91/407 was cited as V O G 900711, the correction is "POG 90051B; 90/412 was cited as I1POG 8852", the correction is "POG 8850'l.

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c. DCI is in receipt of the revised consent form (or other documentation) stipulated for approval of the following protocol which was reviewed at a previous meeting: Outpatient Screening for Sleep Apnea. Hai Bui, CPT, MC, Med. (Feb)

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7. New business:

a. The following protocols, scheduled for continuing review at today’s meeting, were evaluated and approved for continuation by the IRC. Thirteen voting members present and one absentee vote. Approved 13; disapproved 0; abstained 1 (LTC Sherman vested interest).

(1) 85/167 The Effect of Age on Thyroid Function Studies: The Perchlorate Discharge Test. Gerald Kidd, COL, MC, Endo/Med.

(2) 90/112 Laboratory Screening to Detect Biochemical Evidence of Hemochromatosis Among Patients with Non-Insulin Dependent Diabetes Mellitus. John Merenich, MAJ, MC, Endo/Med.

(3) 92/123 A Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Quinapril in Reducing Ischemic Events During a 3-Year Follow-Up -- in Patients Post Intervention: QUIET (Quinapril Ischemic Event Trial). (IND) Parke-Davis Protocol 906-370, Revised 06/27/91; includes Amendments 1 & 2 dated 08/05/91. Richard Davis, COL, MC, Card/Med. Comment: Six month review. Four additional patients were enrolled for a total of 15. Enrollment closed 3 Feb 93. Subjects will be followed for 2 years. Two adverse events (unstable angina and viral infection) were reported in the same patient in a 10-month interval which were not felt to be study drug related.

(4) 92/124 Frequency of Lovastatin and Pravastatin Induced ANA Antibodies and Antibody Identity. Comment: Approve Michael McDermott, LTC, MC, as the new PI vice MAJ Perloff.

(5) 92/125 The Relationship Between High Resolution Electrocardiography and Ventricular Ectopy in Hypertensive Patients with Left Ventricular Hypertrophy: Richard Shea, CPT, MC, Card/Med.

A Pilot Study.

(6) 89/203 Rates of Occurrence of Simultaneous and Independent Low Back Pain and Headache Among Patients with and Without Chronic Pain. Richard Sherman, LTC, MS, Chief, Clinical Biometric.

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HSHG-CI 2 March 1993 SUBSECT: Minutes of the Institutional Review Committee Meeting

Device vs Bone Autograft for the Treatment of Tibial Non-Unions. (IDE) Edward Lisecki, LTC, MC, Orth/Surg. Six month review.

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(7) 92/209 A Randomized Study of the Stryker OP

(8) 92/215 Comparison of Three Pneumatic Compression Devices in 300 Total Hip and Knee Replacement Patients. Edward Lisecki, LTC, MC, Orth/Surg. Six month review.

(9) 92/216 Comparison of Three Postoperative Autologous Blood Transfusion Techniques (Haemonetics Cell Saver, AUTOVAC LF System, and Stryker ConstaVac System) in 300 Total Hip and Knee Replacements. Steven Friedel, CPT, MC, Orth/Surg. Six month review.

(10) 92/217 Hybritech Treatment Protocol: Detection of Colorectal Carcinoma Using Hybri-CEAker in Patients with Primary, Recurrent, Metastatic or Occult Disease. (IND) Bradley Bute, MAJ, MC, Gen Surgery. Comment: Six month review. A total of three patients have been enrolled. An adverse event was reported in one patient which was drug related.

b. The following protocols scheduled for continuing review at this time were reported as completed or terminated:

"-I (1) 92/126 Study of the Effect of Oral Extended-Release Nitroglycerin Capsules in Patients with Angina Pectoris: KV NTG versus Placebo. William Highfill, LTC, MC, Card/Med. Completed.

(2) 92/601 Pontine Lesions on Screening MR (Magnetic Resonance) Imaging of the Brain: Correlation with Cardiovascular Risk Factors. Thomas Damiano, MAJ, MC, Rad. Terminated.

c. The following protocols scheduled for continuing review at this time were completed or terminated at the time of the FY 92 APR:

(1) 88/109 Methotrexate in the Treatment of Steroid Dependent Asthmatics. Thurman Vaughan, MAJ, MC, Allergy-Imm/Med. Completed

(2) 89/111 Multicenter Clinical Evaluation of Penicillin Skin Testing Materials. Richard Weber, COL, MC, Allergy-Imm/Med. Terminated.

(3) 90/113 Effect of Cold Remedies on Metabolic Control of Noninsulin Dependent Diabetes Mellitus. Homer Lemar, MAT, MC, Endo/Med. Completed

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Trial of Dideoxyinosine (ddI) and Dideoxycytidine (ddC) in HIV Infected Patients Who Are Intolerant of or Have Failed Zidovudine (ZDV) Therapy. (IND) Robert H. Gates, LTC, MC, Infect Dis/Med. Terminated.

- (4) 91/128 A Randomized, Open-Label, Comparative

(5) 91/130 MGI 136-07-P90-03: A Double-Blind, Randomized, Placebo Controlled Study of Diethylidithiocarbamate (DDTC) Used as a Protective Agent Against Cisplatin-Induced Toxicities in Patients with Small Cell or Non-Small Cell Carcinoma.(IND) Thomas Cosgriff, COL, MC, Hem-Onc/Med. Terminated.

(6) 88/203 Evaluation of Current Nasal Surgical Techniques Used to Improve Nasal Obstruction (Subjective and Objective), Utilizing Anterior Rhinometric Techniques. Michael Lepore, COL, MC, Otolaryn/Surg. Terminated.

Infants at 6,000 ft Elevation. A Study to Evaluate the Response to a Therapeutic Trial of Iron. Steve Lang, MAJ, MC, Evans ACH, Ft. Carson, CO. Terminated.

(7) 90/900 Iron Deficiency Anemia in 11-14 Month Old

d. The following applications for new clinical investigation

presented today, are identified as follows and include the recommendations rendered in each case by the IRC.

cv projects and amendments, if any, to ongoing protocols which were

(1) Amendment to 92/138 A Double-Blind, Placebo- Controlled, Parallel Group, Multi-Center Study of the Use of Weekly Azithromycin as Prophylaxis Against the Development of Mycobacterium Avium Complex (MAC) Disease in HIV-Infected People. (IND) W.R. Byrne, LTC, MC, Infect Dis/Med.

Comment: Due to FDA approval of rifabutin, the sponsor, Pfizer, recommends currently enrolled subjects sign an addendum in addition to the original informed consent. The consent form has been revised for future patient enrollment. Following a site visit, the Pfizer monitor noted that it was not necessary to revised the consent form as noted in the 5 Jan 93 IRC minutes. The consent form approved in Oct 92 was sufficient. LTC Byrne will PCS 1 Apr 93 and MAJ Konkol will become the new PI at that time.

Recommendations: Approve amendment to protocol and consent form. Approved MAJ Konkol as new PI effective 1 Apr 93. Vote: Approved 14; disapproved 0 ; abstained 0.

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(2)

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Amendment to 92/901 Army Pregnancy Study. Joseph Creedon, CPT, PA-C, Evans ACH, Ft. Carson.

Comment: As expected, results of the pilot study indicate the need for revision to clarify the questionnaire and consent form. These minimal risk changes were expeditiously approved by C, DCI, on 4 Feb 93.

Recommendations: Approve amendment to protocol and consent form. Vote: Approved 14; disapproved 0; abstained 0.

(3) SWOG 9003 Fludarabine for Waldenstrom's Macroglobulinmnia (WM): A Phase I1 Pilot Study for Untreated and Previously Treated Patients. Thomas Cosgriff, COL, MC, Hem- Onc/Med . Comments: separately from data on newly diagnosed patients. Prior therapy may effect treatment response. The consent form quantifies "temporarynt side effects in some places but not in others. Is there a way to quantify all the side effects? Patients are very variable in their responses to the agents. extends beyond the written consent form. Patients are counseled at length regarding their disease and treatment.

Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: MAJ Faragher Gifts: None. Review for Re-approval: One year. Vote: Approved 13; disapproved 0; abstained 1 (COL Cosgriff vested interest).

Data on previously treated patients will be analyzed

The consent process

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(4) SWOG 9031 A Double-Blind, Placebo-Controlled Trial of Daunomycin and Cytosine Arabinoside with or without rhG- CSF in Elderly Patients with Acute Myeloid Leukemia. Thomas Cosgriff, COL, MC, Hem-Onc/Med.

Comments: There is the questions of blast stimulation side effects. This may be a potential toxicity and may make the leukemia worse. The potential for this side effect are outweighed by the consequences of the disease process in elderly patients. There was discussion of adding a precautionary statement to the consent form regarding this risk, NCI approved model informed consent document, which contains all the basic informed consent elements, did not reference this potential toxicity. To meet Army Regulations, considerable information is added to the NCI model consent. At the next meeting the IRC will

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be provided clarification on review of NCI informed consent documents.

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Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: LTC Judson Gifts: None. Review for Re-approval: One year. Vote: Approved 13; disapproved 0; abstained 1 (COL Cosgriff vested interest).

(5) SWOG 9032 A Controlled Trial of Cyclosporine as a Chemotherapy-Resistance Modifier in Blast Phase Chronic Myelogenous Leukemia. Thomas Cosgriff, COL, MC, Hem-Onc/Med.

Comments: None. Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: LTC Judson Gifts: None. Review for Re-approval: One year. Vote: Approved 13; disapproved 0; abstained 1 (COL Cosgriff vested interest).

- (6) SWOG 9133 Randomized Trial of Subtotal Nodal Irradiation vs. Doxorubicin Plus Vinblastine and Subtotal Nodal Irradiation for Stage I-IIA Hodgkin's Disease, Phase 111. Thomas Cosgriff, COL, MC, Hem-Onc/Med.

Comments: Analysis is stratified by age. Age is very important in the prognosis of Hodgkin's. Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: LTC Judson Gifts: None. Review for Re-approval: One year. Vote: Approved 13; disapproved 0; abstained 1 (COL Cosgriff vested interest).

There is a bimodal curve.

(7) POG 8935 A Study of the Biological Behavior of Optic Pathway Tumors. George Maher, MAJ, MC, Ped Onc.

Comments: These tumors respresent about 5% of all pediatric malignancies. In the past 2 years none were seen at FAMC.

Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: COL Bruhn Gifts: None.


Review for Re-approval: One year. Vote: Approved 14; disapproved 0; abstained 0.

Treatment of Children with Recurrent or Progressive CNS Tumors. A Phase I1 Study. George Maher, MAJ, MC, Ped Onc.

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(8) POG 9060 Intensive QOD Ifosfamide for the

Comments: None. Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: COL Bruhn Gifts: None. Review for Re-approval: One year. Vote: Approved 14; disapproved 0; abstained 0.

(9) POG 9170 Etoposide and Ifosfamide plus G-CSF in Children with Sarcomas; including Soft Tissue Sarcoma, Ewing's Sarcoma, Rhabdomyosarcomas and Osteosarcoma. A Pediatric Oncology Group Pilot Study. George Maher, MAT, MC, Ped Onc.

Comments: This is a last line treatment after all other therapies have failed. The purpose of the study is to determine the maximum tolerated dose and then compare that in a randomized fashion.

Recommendations: Protocol and consent form approved. Risk Factor: More Than Minimal Risk. Medical Monitor: COL Bruhn Gifts: None. Review for Re-approval: One year. Vote: Approved 14; disapproved 0; abstained 0.

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(10) A Randomized, Double-Blind, Placebo-Controlled, Partial Crossover Study of Combination Topical Nitroglycerin and Yohimbine Therapy on Erectile Dysfunction in Diabetics. Christina Manthos, CPT, MC, Urol/Surg.

Comments: In the protocol "nitrous oxide" is an incorrect term. The Chief of Department of Surgery should sign the protocol. The Pharmacy Impact Statement was signed. The protocol and consent form refer to a questionnaire and data forms. These should be sent to DCI. The study design is asymmetric in that there is no double placebo. with both drugs in the last 10 weeks. The purpose of the study is to look f o r synergy.

LTC Donatucci presented the study to the Committee.

The purpose is to see if the patients lose efficacy

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Recommendations: Protocol approved pending receipt of the consent form revised to Judge Advocate stipulations, and other stipulations as noted above. Risk Factor: More Than Minimal Risk. Medical Monitors: COL Kidd and MAJ Sutherland Gifts: None. Review for Re-approval: One year. Vote: Approved 14; disapproved 0 ; abstained 0.

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(11) Comparison of Cementless Hydroxyapatite-Coated vs Cementless Non-Hydroxyapatite-Coated vs Cemented Ortholoc Advantim Total Knee Systems.(IDE) Edward Lisecki, LTC, MC, Orth/Surg.

Comments: This investigational device exemption has not yet been approved by the FDA. When the IDE is granted, the study will be initiated, but not before. The cemented device portion of the protocol will be performed at other institutions. There is no additional patient care from the routine treatment.

Recommendations: consent form revised to Judge Advocate stipulations. Risk Factor: More Than Minimal Risk. Medical Monitor: MAJ Place

data coordinator. Review for Re-approval: One year. Requires approval by HSC to participate in an IDE study.

Vote: Approved 14; disapproved 0; abstained 0.

Protocol approved pending receipt of the

_I Gifts: Colorado Biomedical (non-profit corp.) will provide a

(12) Comparison of Femoral Hip Prosthesis Micromotion Between Eight Types of Prosthetic Devices: Edward Lisecki, LTC, MC, Orth/Surg.

Comments: The variability of femoral stems will be decreased by matching controls, Radiographs will be obtained to template the specimens. disposing of the specimens. Chief of Pathology has signed an impact statement agreeing to dispose of the specimens in the appropriate manner.

A Cadaveric Study.

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Appropriate precautions will be taken in handling and

Recommendations: Protocol approved. Risk Factor: Minimal Risk. Medical Monitor: Not applicable. Gifts: None. Review for Re-approval: One year. Vote: Approv.ed 14; disapproved 0; abstained 0.

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HSHG-CI 2 March 1993 SUBTECT: Minutes of the Institutional Review Committee Meeting

Pressure. John Hagan, CPT, MC, Neph/Med.

Comments: This will be a 52-hr recording. A period of 2-6 a.m. will be isolated for analysis of variance over time. This is the time of least variance. The comfort of wear the blood pressure cuff was discussed. Most patients have been able to sleep while wearing the cuff. The possible discomfort of wearing the cuff was discussed in the consent form, but not the actual procedure of wearing the cuff. The protocol and consent form reference forms that were not included with the protocol, which it turns out are standard forms---DA Form 4106, DA Form 4700, and DA Form 5134-R. Is 5mm blood pressure difference large enough to be significant? Epidemiologic studies indicate this is a significant difference in long-term outcomes of the patients.

Recommendations: Protocol approved pending receipt of the consent form revised to Judge Advocate stipulations. Risk Factor: Minimal Risk. Medical Monitor: CPT Yeun Gifts: None. Review for Re-approval: One year. Vote: Approved 14; disapproved 0; abstained 0.

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(13) The Effects of Altered Magnesium on Blood

-~ 8. Other business:

a. On 25 Jan 93 HCS-CIA approved the IND study, 92/142 Clarithromycin in Combination with Omeprazole or Omeprazole as a Single Agent for the Treatment of Patients with Duodenal Ulcers, by LTC McNally.

b. On 2 Feb 93 MAJ Sherman approved the addition of Lena Smith, DAC, as Associate Investigator on protocol, 93/402 The False Negative Rate of Denver I1 in FAMC Pediatric Population 7- 36 months of Age. The IRC unanimously approved this additional investigator.

c. On 8 Feb 93 additional adverse experience reports were received on protocol, 92/127 A Phase 111, Randomized Comparative Trial of ZDV versus ZDV plus ddI versus ZDV plus ddC in HIV-Infected Patients (NUCOMBO). William R. Byrne, LTC, MC, Infect Dis/Med. experienced no adverse effects.

Patients currently enrolled at FAMC have

d. On 12 Feb 93 LTC Harrison, Chief, CIP, HSC, telephonically gave approval to MAJ George Maher for emergency treatment of acute lymphoblastic leukemia with IV 6-MP (mercaptopurine, IND#220) in pediatric patient, D.B.

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e. It was called to the attention of the Committee and audience that investigators cannot enter into direct fee-for- services contractual agreements with companies sponsoring studies. Investigator agreements should be reviewed by DCI and the Judge Advocate prior to signing.

9. the Institutional Review Committee members with the stipulations and exceptions as noted.

All protocols have been moved and seconded for approval by

10. There being no further business, the meeting was adjourned at 1500.

NOTE: Any revisions suggested by IRC members as a contingency for approval of a study presented today have been noted. Following legal clearance of revised consent forms, if any, by the FAMC Staff Judge Advocate, the protocols will be submitted to the Commander, HSC, for review and extended approval, if indicated.

I__ Encls Chief, Dept of Clinical Investigation Acting Chairman, IRC

DISTRIBUTION 1. Committee Members 2. Principal Investigators

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HSHG-ZA(HSHG-C1/2 Mar 93) (15-la) 1st Ind BG Bowen/

SUBJECT: Minutes of the Institutional Review Committee Meeting mb/DSN 943-8407 .-

Commander, Fitzsimons Amy Medical Center, Aurora, CO 80045-5000

FOR Chairman, Institutional Review Committee, Fitzsimons Army Medical Center, Aurora, CO 80045-5000

Minutes for the Institutional Review Committee Meeting have been reviewed and approved.

Encls THOMAS E. BOWEN Brigadier General, MC Commanding

Date Signed by Commander 10 M & 4 3

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Minutes of the I - OSTI.GOV

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