ML20078F522

Submits Summary of Review for First Three Patients Re Neutron Capture Therapy Trials

ML20078F522
Person / Time
Site:	MIT Nuclear Research Reactor
Issue date:	01/24/1995
From:	Bernard J MASSACHUSETTS INSTITUTE OF TECHNOLOGY, CAMBRIDGE
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
NUDOCS 9502020138
Download: ML20078F522 (3)

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NUCLEAR REACTOR LABORATORY' AN INTERDEPARTMENTAL CENTER OF MASSACHUSETTS INSTITUTE OF TECHNOLOGY

0. K. HARLING 138 Albany Street. Cambridge, Mass. 02139-4296 J. A. BERNARD. JR.

Telefax No. (617) 253-7300 Director of Reactor Operations Doctor ,

Telex No. 92-1473 MIT CAM l l

Tel. No. (617) 253 4202 i

i January 24,1995 ,

U.S. Nuclear Regulatory Commission u

Washington, D.C. 20555 Attn: Document Contml Desk

Subject:

Status of Neutron Capture 'Iherapy Trials t

Gentlemen:

As you are aware, the Massachusetts Institute of Technology initiated trials of Neutron Capture Thera py on 6 Sept.1994 under a Phase I protocol that is required by the U.S. Food and Drug Ad ministration. A second irradiation series was initiated on 10/24/94 and a third on 12A)5/94. The pmtocol stipulates that a review is to be done following each -

group of three patients. If no adverse effects are noted, then the dose can be increased by 250 RBE-cGy. Enclosed is a summary of the review for the first three patients. We are r providing this to you as an item of information. Its submission is not required. We wish to call your attention to two items in the summary. First, the normal tissue response for all '

three subjects (the word " subject" is used in lieu of " patient" because it's a Phase I study) was graded as "0". That is, no adverse effects occurred to healthy tissue. Second, the i third subject's tumor module was markedly reduced in size. Uptake of boron varies substantially from patient to patient and the third subject had a much higher uptake of boron  !

than the first two. Each subject received the same dose (1000 RBE-cGY) to kalthy tissue.

Hence, a subject with a higher boron uptake would get more dose to tumor. This explains -

t the tumor reduction observed in the third subject.

i Sincerely, .

,Qd -

ohn A. Bernard, Ph.D.

Director of Reactor Operations  :

MIT Research Reactor JAB /CRM cc: USNRC - Project Manager, NRR/ONDD USNRC - Region I- Pmject Scientist, ,

Ef0uents Radiation Protection Section (ERPS) .

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TECIINICAL PROGRESS REPORT - UPDATE DE FG02-87ER60600

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• UPDA TE TO JANUARY 23, 1995*** '

BRIEF REVIEW OF TIIE FIRST TilREE EXPERIMENTAL IRRADIATIONS OF IIUMAN SUBJECTS UNDER TIIE APPROVED BNCT MELANOMA PROTOCOL Robert G. Zamenhof, Ph.D., NEMC, and Otto K. Ilarling, Ph.D., MIT He first three subjects have completed their BNCT irradiations under the approved melanoma protocol. This constitutes the subjects in the first-lowest dose level group, requiring 1,000 RBE-cGy maximum dose to normal tissues. The following is a very brief review of these clinical trials.

General Test dose of BPA 400 mg/kg, biodistribution (blood) and (punch) biopsies before irradiations.

Four (4) fractions with 400 mg/kg of BPA.

Blood samples before and after irradiation, punch biopsy before start of first fraction.

Each fraction ~ 250 RBE-cGy.

Total dose 1,000 RBE-cGy to nomul tissue, delivered over 1-2 weeks.

No problems were experienced,

l. Sublect No. 94 66-venr old male. first fraction Sentember 6.1994 Melanoma on plantar surface of right foot. BPA and neutron irradiation administered as per protocol: Foot phantom constructed and dosimetry measurement made before fp' st  :

trradiations, retrospectively the Cr based Monte Carlo tregment plan completed; luB blood l timecourse study completed; tissue biopsies analyzed for WB; clinical exams completed; 2,000 mg/kg total oral 1,BPA administered as 400 mg/kg x 5; combined with four fractions of epithermal neutron delivery to selected tumor site. No untoward events related to l subject.

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Follow-uo: Normal tissue reaction graded as "O". No visible tumor response.  ;

2. Sublect No. 94 2 year-old male. first fraction October 24. 1994

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Melanoma on medial surface of left lower leg. BPA and neutron irradiation administered as )'

per protocol: Cr based Monte Carlo tgatment plan completed before first fraction and compared to experimep,tal dosimetry; WB blood timecourse study completed; tissue biopsies analyzed for WB; clinical exams completed: 2,000 mg/kg total oral 1,BPa administered as 400 mg/kg x 5; combined with four fractions of epithermal neutron delivery to selected tumor site. No untoward events related to subject.

Follow uo: Normal tissue reaction graded as "0". No visible tumor response.

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3. Subiect No. 94 81 venr-old female. first fraction December 5.1994

' Melanoma on outer surface of left lower 4 BPA and rieutron irradiation administered as >

per protocol: Cr based Monte Carlo 2 nt plan completed before first fraction and compared to experimeppl dosimetry; : 1xxl timecourse study completed; tissue biopsies analyzed for mB; clinical exam :npleted; 2,000 mg/kg total oral 1,BPA administered as 400 mg/kg x 5; combine. rh four fractions of epithermal neutron -

delivery to selected tumor site. No untow events related to subject.

Follow-up: normal tissue reaction graded as 0". Visible tumorirsponse involving redness and blistering of tumor nodules in radiation field (but not those outside) one day -

after final treatment. Subject reported diminished size of tumor nodules in field 4 days after final treatment with resolution of redness and blistering. First follow-up by NEMC clinicians, one month after last fraction, showed rumor nodules in radiation field markedly reduced in size, but one of those outside radiation field somewhat increased in size.

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