ML20012A970

Voided Matls Licensing Action for License 37-02562-01 for Hosp of Medical College of Pennsylvania.Control:110031

ML20012A970
Person / Time
Issue date:	06/03/1989
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	NRC OFFICE OF THE CONTROLLER
References
110031, NUDOCS 9003130129
Download: ML20012A970 (14)

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INFORMATION FROM LTS O SETWEEN.

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HOSP. OF THE MEDICAL C3LLEGE OF PA RECEIVED DATE:,

851227 O-DOCKET NO:

3003022 CONTROL NO.:

110031 LICEN SE NO. :

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License No. 37-02562-01 Docket No. 030-03022 Control No. 110031 t

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Medical Center of Pennsylvania ATTN: Barry Miller, Ph.D.

Associate Dean 3300 Henry Avenue.

E Philadelphia, Pennsylvania 19129 i

Gentlemen:

This is in reference to your letter dated October 13, 1988 to amend License No.

37-07438-15. We have determined that this human use should be authorized under your License No. 37-02562-01.

In order to act upon your request, we need the following additional information:

Since this study is being conducted, in part, to determine the safety

-and efficacy of a new drug, the NRC requires that you obtain an IND from the Food and Drug Administration prior to authorizing'this study.

You may use a copy of this letter to establish the NRC's need for an IND.

Please reply in duplicate and refer to Control No. 110031.

Sincerely, Original signed By:

John E. Glenn, Ph.D.

John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section A Division of Radiation Safety and Safeguards n

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The Medical College of Pennsylvania Office of the Associate Dean for Research (215)8424135 October 13, 1988 p.

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Nuclear Materials Safety Section A Division of Radiation Safety & Safeguards f

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United States Nuclear Regulatory Commission f[

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Ret Request for Amendment ?'~ ~ 'A ~ : ~

NRC Lic. #37-07438-1S Gentlement This is a request for amendment of our limited broadscope license #37-07438-15 permitting one of our internal licensees to employ Tritium in a research study in humans.

The study would be conducted by Davi~d M. Capuzzi, M.D., Ph.D., in the 4"

Departments of Medicine and Physiology / Biochemistry. A brief summary of this project entitled "Ef fects of Wytensin Upon7 Kinetics of Lipoprotein i

Metabolism of Patients with Essential Hypertension and Hyperlipidemia" is attached as excerpted from Dr. Capuzzi's~ application to the Radiation Safety Committee for internal license. Also enclosed is the: license application page submitted by Dr. Capuzzi on which his qualifications and experience have been listed.

E A

We request the Commission, in their review to note that the project is strictly limited in its-scope and will involve a' maximum of twenty adult volunteers, each to be studied twice at an interval ofisix to eight weeks.

Pregnant females will, of course, be excluded from thelgroup studied. A dose of 300 uCi. of tritiated glycerol will be administered to each volunteer for each study. The project will begin within a week or so of l

recoipt of amendment and will terminate within about six months. Within 30 days of termination, a brief report summarizing'results, listing problems, if any, and officially notifying the NRC of completion will be issued.

Dr. Capuzzi's application for internal license at MCP has been approved by the Radiation Safety Committee, conditional on receipt of amendment of l

the MCP limited broadscope license permitting this specific work in humans.

l 1$g. esearch protocol has also been approved by the Committee for the Prot dtipp Human Subjects and evidence of this approval is enclosed.

I No/p OFFICIAL RECORD COPY Mt.10

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at Eastern Pennsylvania Psychiatric Institute

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$ENRY AVENUE PHILADELPHIA. PENNSYLVANIA 19129 jq_47-gg w.o Tne rern;re seacar conege of eennigana ise7 The woman. med cal College of Penns/vania 1970 Tbe Medical College of Penns/vana

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,..i Page Two USNRC Region I -

Request for Amendment, MCP Limited Broadscope Lic. #37-07438-15 October 13, 1988 It is not anticipated that this procedure will create any radiation safety problems within the Clinical Research Unit located at Eastern Pennsylvania Psychiatric Institute (EPPI) either for laboratory or hospital workers and the volunteer's stay after administration of the tritiated glycerol is expected to be no longer than 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> each visit. Whole body dose to volunteers, for each 300 uCi. of H-3 administered, will be less than 600 mrem Ref.:

Pedersen, N.T., Marqversen, J.:

" Metabolism of Injected C-14 Triolein.

Estimation of Radiation Dose in Tests of Lipid Assimilation Using C-14 and H-3 Labelled Fatty Acids." European Journal of Nuclear Medicine 6:327, 1981. Cited in Harbert, J.C. & Pollina, R:

" Absorbed Dose Estimates from Radionuclides," Clinical Nuclear Medicine, 9:210, 1984.

Owing partly to the fact that MCP License #37-07438-15 has been under review for renewal through a major portion of 1988 and partly to difficulties in internal review of this project by various committees at MCP, time has become a most serious factor and, for this reason, we urgently request as prompt a review of this amendment application as is possible. A check for $120 is enclosed as per 10 CFR 170.31, 7.B.

If there are questions about the application, please contact Wayne A. Meyers, R.S.O. at (215)842-6588.

Sincerely, f6 W

Barry Miller, Ph.D.

Associate Dean for Research BM:cht Encls: Description of experimental protocol (Item 4. Int. Lic. Form)

Training and Experience (Item 8, Int. Lic. Form) 4 Approval Letter, Committee for the Protection of Human Subjects Check

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.s i-USNRC, Region I -

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Request for Amendment. MCP Limited Broadscope Lic.

1. 37-07438-15 l

ENCLOSURE:

r Description of experimental protocol, excerpted from Item 4, application by David M. Capuzzi, M.D., for internal license at MCP:

Twenty patients (eight with mild-to-moderate essential hypertension) and twelve with the same kind of hypertension but with type iia or iib primary hyperlipoproteinemia will have their antihypertensive medication discontinued (washout period) for one month as per protocol. They will be admitted in pairs as inpatients in the Clinical Research Unit at EPPI after a prior period of appropriate dietary preparation and placed on a low cholesterol, low saturated fat diet during their inpatient stay.

They will then be placed on a specially prepared liquid formula diet for 36 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> and then will be given 300 uCi. of tritiated glycerol and several blood samples will be taken from an indwelling catheter at intervals over the next 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period while an intravenous solution of 5% glucose is infused. These samples will be analyzed for lipid and lipoprotein radioactivity.

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Each patient will then be placed on guanabenz, an approved antihypertensive medication with hypolipidemic properties for six to eight weeks and each patient will be re-admitted to the CRU to have the same procedures carried out again as described above. An estimation of labeled VLDL turnover in the absence and in the presence of that medication will be determined.

Patients will then either return to their original treatment regimen or will be placed on guanabenz (Wytensin) for management purposes. All guidelines and safety measures as dictated by the Committee for the Protection of Human Subjects and by the Radiation Safety Committee will be followsd strictly.

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MCP Th medical coiiege or Pennsylvania e

(115)842 4166/67 l

October 12, 1988 RE:

Effects of Wytensin Upon Kinetics of Lipoprotein Metabolism of patients with Essential Hypertension and Hyperlipidemia Dear Dr. Capuzzi me Mttee for the Protection of Human Subjects has approved your protocol for research. Your consent form must contain the protocol number and date of approval by the Comittee as follows:

protocol No.:

87-87 Date of Approval 10/16/87 We &ief Investigator must adhere to the following:

1.

The Consmittee must be notified whether or not a grant is approved and funded and date when project will begin if a research grant is submitted based on this study.

2.

Any changes in the protocol for research or method of informed consent must be approved by the CPHS before inplementation.

Both the Committee and the patient must be notified of any new toxicity data. It may be necessary to modify the protocol and seek reapproval.

3.

In the case of a drug, the CPHS requests assurance that the Pharmacy will be the site of storage and dispensing of the drug; or, that a central, secure place where drug can be locked and accounted for will be used.

4.

The consent form must bear the official approval stamp of the CPHS.

It must remain with the patient's chart.

5.

If the study impacts on several departments, the appropriate departments and administrative heads must be contacted.

A continuing review form (pregress report) will be due in one year.

A form will be sent to you.

Sincere y yours,

/

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~. Ogburn, Ph.D.

Clift < in A

&airlwin Comittee for the Protection of Human Subjects at Eastem 1%nnsylvania Psychiatric Institute 3300 HENRY AVENUE PHILADELPHIA PENNSYLVANIA 19129

'1850 The female Medical College of Pennsylvania 1867 The womans Med<al College of Pennsylvania 1970 The Medical College of Pennsyhania

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g y Describe means by which you in tend to dispose of radioactive wa'g;id and estimate yearly waste disposal amounts of each nuclide name'n. h Item 3.

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collaboration with Dr. Marsh and Dr. Itothblat in the Biochemistry

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TRAINING AND EXPERIENCE OF APPLICANT WITH RADIOACTIVE MATERIALS In addition to completing this item, copies of anydocumentatiorb pi '!- 'i i

supporting training, such as a Curriculum Vitae, would be h e lp f t.

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Personal Experience with Radionuclides :

Quantities Handled f

RGdionuclide Maximum Where Experience Duration of Type 3g,14c,125 3

1 Amount In was Gained Experience (E.g.

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The Medical College of Pennsylvania Office of the Associate Dean for Research h

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2 October 13, 1988 j) L W c

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[y Nuclear Materials Safety Section A l

Division of Radiation Safety & Safeguards o

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Region I d

475 Allendale Road King of Prussia, PA 19406 p:,[O Ret Request for Amendment, l

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NRC Lic. #37-07438-15 L

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1 Gentlemen:

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This is a request for amendment of our limited broadscope license #37-t 07438-15 permitting one of our internal licensees to employ Tritium in a bk i

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M research study in humans.

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M I' j l 5-The study would be conducted by David M. Capuzzi, M.D., Ph.D., in the 3

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d Departments of Medicine and Physiology / Biochemistry. A brief summary of 3 ?

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this project entitled " Effects of Wytensin Upon Kinetics of Lipoprotein

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Metabolism of Patients with Essential Hypertension and Hyperlipidemia" is attached as purpted from Dr. Capuzzi's application to the Radiation Safety Comittee for internal license. Also enclosed is the license application 4

page submitted by Dr. Capuzzi on which his qualifications and experience

[

have been listed, p

4 We request the Commission, in their review, to note that the project is j,f strictly limited in its scope and will involve a maximum of twenty adult j

j fji volunteers, each to be studied twice at an interval of six to eight weeks.

j

! q l Pregnant females will, of course, be excluded from the group studied. A p

j l p dose of 300 uCi. of tritiated glycerol will be administered to each 4

i y volunteer for each study. The project will begin within a week or so of Q i i

receipt of amendment and vill terminate within about six months. Within 30 Q j f days of termination, a brief report summarizing results, listing problems, y y 'f d y if any, and officially notifying the NRC of completion will be issued.

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Dr. Capuzzi's application for internal license at MCP has been approved p gn by the Radiation Safety Committee, conditional on receipt of amendment of g j @

the MCP limited broadscope license permitting this specific work in humans. k- @

i ;l q The research protocol has also been approved by the Committee for the Protection of Human Subjects and evidence of this approval is enclosed.

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at Eastern Pennsylvania Psychlatric Institute

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3200 HENRY AVENCIE PHILADELPHIA, PENNSYLVANIA 19129

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Request for Amendment, MCP Limited Broadscope Lic. #37-07438-J1 October 13, 1988 iJ J j;~J k

@{'I It is not anticipated that this procedure will create any radiation i

safety problems within the Clinical Research Unit located at Eastern 5

Pennsylvania Psychiatric Institute (EPPI) either for laboratory or hospital 5

workers and the volunteer's stay after administration of the tritiated glycerol is expected to be no longer than 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> each visit. Whole body f

dose to volunteers, for each 300 uC1. of H-3 administered, will be less than 1-t 600 mrem Ref.:

Pedersen, N.T., Marqversen, J.:

"Metabolirm of Injected I- ;

C-14 Triolein.

Estimation of Radiation Dose in Tests of Lipid Assimilation p

Using C-14 and H-3 Labelled Fatty Acids," European Journal of Nuclear r

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Medicine 6:327, 1981. Cited in Harbert, J.C. & Pollina, R:

" Absorbed Dose j

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Estimates from Radionuclides," Clinical Nuclear Medicine, 9:210. 1984.

- p Owing partly to the fact that MCP License 1137-07438-15 has been under b

( 'f %K review for renewal through a major portion of 1988 and partly to difficulties in internal review of this project by various committees at ll

.s MCP, time has become a most serious factor and, for this reason, we urgently j.

iN c

' l request as prompt a review of this amendment application as is possible. A (M

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check for $120 is enclosed as per 10 CFR 170.31, 7.B.

If there are questions about the application, please contact Wayne A. Meyers, R.S.O. at

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L (215)842-6588.

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d ldqh Sincerely, h@. M}

Barry Miller, Ph.D.

M' Associate Dean for Research y

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i BMichr Encls: Description of experimental protocol (Item 4, Int. Lic. Form)

Ii Training and Experience (Item 8, Int. Lic. Form) c A

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Request for Amendment. MCP Limited Broadscope Lic.

(137-07438-15

h h.

fh ENCLOSURE:

(n ji Description of experimental protocol, excerpted from Item 4, 1

application by David M. Capuzzi, M.D., for internal license at MCP:

d yr hypertension) and twelve with the same kind of hypertension but htNL)i Twenty patients (eight with mild-to-moderate essential M!

with type iia or iib primary hyperlipoproteinemia will have their

[

antihypertensive medication discontinued (washout period) for one

g month as per protocol. They will be admitted in pairs as

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,g inpatients in the Clinical Research Unit at EPPI after a prior period _of appropriate dietary preparation and placed on a low

j-cholesterol, low saturated fat diet during their inpatient stay.

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, l jl They will then be placed on a specially prepared liquid formula "4

3 diet for 36 hours4.166667e-4 days <br />0.01 hours <br />5.952381e-5 weeks <br />1.3698e-5 months <br /> and then will be given 300 uCi. of tritiated p j f glycerol and several blood samples will be taken from an b

Je indwelling catheter at intervals over the next 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period

@ df samples will be analyzed for lipid and lipoprotein radioactivity.

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, (}l while an intravenous solution of 5% glucose is infused. These q

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Each patient will then be placed on guanabenz, an approved j j L' antihypertensive medication with hypolipidemic properties for six M

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to eight weeks and each patient will be re-admitted to the CRU to have the same procedures carried out again as described above. An A

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estimation of labeled VLDL turnover in the absence and in the t ;;;

presence of that medication will be determined.

Patients will j, j then either return to their original treatment regimen or will be 4

1: i-i f!j%j[

placed on guanabenz (Wytensin) for management purposes. All guidelines and safety measures as dictated by the Committee for

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j the Protection of Human Subjects and by the Radiation Safety a

Committee will be followed strictly.

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and estimate yearly wasta disposal amounts of Item 3.

each nuclide namejfj $

. ft ll g Counting vials and liquid waste will be disposed of caramercially l {

collaboration with Dr. Marsh and Dr. Itothblat in the Diochemistry physiology Department.

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TRAINING AND EXPERIENCE OF APPLICANT WITil RADIOACTIVE MA 1

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i}p In addition to completing this item, copies of any documentatior

' Y supporting training, such as a curriculum Vitae, would be helpftQ

. j y yy Type of Training Where When Total On the Forma N Trained (Dates) flours Job Courty.h,L.]

m c.

Principles and John ilo;) kins 9-1967 Approx.

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to the use and 6-1969 graduate hf

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October 12, 1988 h [

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d RE:

Effects of Wytensin Upon Kinetics of Lipoprotein Metabolism of f

,' M Patients with Essential !!ypertension and flyperlipidemia I

. [ d I

1 Dear Dr. Capuzzi

'Ihe Consmittee for the Protection of }{dman Subjects has approved your

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protocol for research. Your consent form must contain the protocol l

number. and date of approval by the Committee as follows:

(

Protocol No.:

87-87 Date of Approval 10/16/87 The Chief Investigator must adhere to the followings i f j h 1

. ? K

[

q 1.

The Consnittee must be notified whether or not a grant is approved

]j:

and funded and date when project will begin if a research grant

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is submitted based on this study.

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y a

2.

Any changes in the protocol for research or method of informed

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consent must be approved by the cpl!S before inplementation.

I i Both the -committee and the patient must be notified of any new 4

4 toxicity data.

It may be necessary to modify the protocol and Jh j !j i

4 seek reapproval.

3.

In the case of a drug, the cpl!S requests assurance that the Pharmacy will be the site of storage and dispensing of the drugs or, th*it a central, secure place where drug can be locked and accounted for will be used.

c;'

4.

The consent form must bear the official approval stamp of the CritS.

kIb;d h{gy!

It must remain with the patient's chart.

,l S.

If the study impacts on several departraents, the appropriate departments 4 f L y

and administrative heads must be contacted.

h A continuing review form (progress report) will be due in one year. A y

h )

F forin will be sent to you, h

1 Sincere y yours, I j q

[.b h

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0 Clifti >n A. Ogburn, Ph.D.

4 ;'hj p

Chairumn N

Committee for the Protection of Iluman Subjects Offl0IAL RECORD COPY AE 10 A$000$

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