Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed 15 and over NCI-D82-004-688 BTRC-8222

Objectives

I.  Determine the therapeutic efficacy of radiosensitization with 
5-bromodeoxyuridine, radiotherapy, and chemotherapy with PCV 
(procarbazine/CCNU/vincristine) vs. the same treatment without 
radiosensitization in historical controls for the treatment of primary 
malignant brain tumors.
II.  Compare these patients to historical controls with respect to time to 
disease recurrence or progression, response rates and durations of response, 
survival time, quality of life, and activity level.
III.  Determine the safety of the iv infusion schedule for 5-bromodeoxyuridine.
IV.  Determine the ability of 5-bromodeoxyuridine infusions to maintain plasma 
levels at 10 to the negative fifth M.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with primary intracranial 
malignant glioma proven by surgical biopsy or by clinical, neurologic, and 
neuroradiologic evidence that supports no other diagnosis.  Eligible tumor 
types include glioblastoma multiforme, Grade III-IV astrocytoma, anaplastic 
astrocytoma, gemistocytic astrocytoma, and malignant glioma not otherwise 
specified.  Patients must be at least 15 years of age and have a minimum life 
expectancy of 8 weeks; therapy should begin within 4 weeks of surgical or 
clinical diagnosis.  There may have been no prior cytotoxic chemotherapy or 
radiotherapy; liver, kidney, and bone marrow function must be adequate, and 
the Karnofsky performance status must be at least 70 percent at the time of 
entry.  Patients may or may not have had prior surgery.

Expected Enrollment

50 patients in each of the two tumor histologic stratification groups will be 
entered over about 3 years.  Protocol closed January 1983.

Outline

Nonrandomized study.
Radiotherapy with Radiosensitization.  Whole-brain irradiation using 
megavoltage equipment; 5-Bromodeoxyuridine, BUdR, NSC-38297.
3-Drug Combination Chemotherapy.  PCV:  Procarbazine, PCB, NSC-77213; CCNU, 
NSC-79037; Vincristine, VCR, NSC-67574.

Phuphanich S, Levin EM, Levin VA: Phase I study of intravenous bromodeoxyuridine used concomitantly with radiation therapy in patients with primary malignant brain tumors. Int J Radiat Oncol Biol Phys 10 (9): 1769-72, 1984.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Northern California Cancer Center

Victor Levin, MD, Protocol chair		Ph: 713-792-8297; 800-392-1611 Email: vlevin@mdanderson.org