# INTRAARTERIAL BUDR RADIOSENSITIZATION-MALIGNANT

> **NIH NIH R01** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 1988 · $129,295

## Abstract

The purpose of this phase I/II study is to develop an improved treatment
program for patients with unilateral malignant cerebral gliomas using
intra-arterial (IA) infusions of a radiosensitizing drug in conjunction
with radiotherapy.  The results of a recent study indicate that carotid
infusion of BUdR should deliver an 11- to 16-fold higher concentration of
BUdR to cerebral tumors compared to intravenous (IV) administration.  It
was concluded that a safe carotid delivery system is necessary to maximize
the efficacy of BUdR.  We have developed such a carotid drug delivery
system and propose to utilize it for investigations in monkeys and clinical
trials in man.

Prior to human studies, we will examine the effects of IA BUdR and
radiotherapy on the normal primate brain.  These studies have been
requested by the National Cancer Institute and the Food and Drug
Administration prior to the initiation of human clinical trials.  We will
also determine the regional advantage of IA BUdR and 5-FU by measuring the
internal carotid artery blood levels of BUdR and 5-FU in the monkey after
both intracarotid and IV administration.  5-FU will be studied because of
its potential to increase BUdR incorporation into DNA and enhance BUdR
radiosensitization.

A phase I/II clinical trial of IA BUdR and radiotherapy will begin after
the completion of primate toxicity studies.  Patients will undergo a
craniotomy for diagnosis and maximum resection of their tumors, followed
one week later by placement of a totally implantable pump capable of
delivering drugs by either bolus or continuous infusion directly into the
internal carotid artery.  They will receive continuous infusion of the
radiosensitizer BUdR at 500 mg/m2/day.  The infusion will begin 14 days
prior to and continue during radiation therapy.  Radiation therapy will
consist of 6000 rads delivered to the tumor bed and a 3 cm margin.
Patients whose tumors fail radiosensitization and radiotherapy will receive
intermittent bolus infusions of high dose BCNU (150 mg/m2) via the pump
sideport at 6-week intervals.

We anticipate that this study will further knowledge about the IA
administration of radiosensitizers and chemotherapeutic agents.  We further
hope this treatment program will increase survival for patients with
malignant gliomas and eventually lead to the development of Phase III
cooperative studies.

## Key facts

- **NIH application ID:** 3171569
- **Project number:** 5R01CA033768-03
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **SAM.gov UEI:** GNJ7BBP73WE9
- **Principal Investigator:** HARRY S GREENBERG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1988
- **Award amount:** $129,295
- **Award type:** 5
- **Project period:** 1986-05-01 → 1990-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3171569

## Citation

> US National Institutes of Health, RePORTER application 3171569, INTRAARTERIAL BUDR RADIOSENSITIZATION-MALIGNANT (5R01CA033768-03). Retrieved via MORVS 2026-10-24 from https://api.morvs.ai/grant/nih/3171569. Licensed CC0.

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