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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed 18 to 80 NCI OSU-8503 NCI-T85-0058D, T85-0058

Objectives

I.  Compare survival rates after therapy with either diaziquone or carmustine 
as initial drug therapy in patients with primary tumors of the central nervous 
system.
II.  Determine the rate and duration of response to therapy with either 
diaziquone or carmustine in patients with malignant primary tumors of the 
central nervous system.
III.  Compare the tolerance and toxicity of both drugs in these patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between the ages of 18 and 
80 with histologically proven Grade III/IV astrocytoma (glioblastoma 
multiforme) who have failed or who are not considered candidates for surgery 
and/or radiotherapy.  Disease must be measurable.  Prior chemotherapy 
excludes, and patients must be on stable or decreasing doses of maintenance 
steroids.  At least 6 weeks must have elapsed since prior radiotherapy (unless 
there is evidence of tumor progression during or after radiotherapy, 
documented by successive CAT scans performed at least 2 weeks apart).  There 
must be recovery from prior radiotherapeutic toxicity, i.e., absolute 
granulocyte and platelet counts must be greater than 1,500 and 150,000/cumm, 
respectively.  A life expectancy of more than 4 weeks and adequate hepatic and 
renal function are required.  Patients who require concurrent systemic 
chemotherapy with other agents, intracavitary/intrathecal chemotherapy, or 
radiotherapy are excluded as are those with more than one primary malignancy 
and those with other neurologic illnesses (e.g., dementia, multiple sclerosis, 
amyotrophic lateral sclerosis) that would obscure the evaluation of therapy.  
Pregnant and lactating females are ineligible.

Expected Enrollment

110 patients will be entered per arm over approximately 3 years.

Outline

Randomized study.
Arm I:  Single-agent Chemotherapy.  Diaziquone, Aziridinylbenzoquinone, AZQ, 
NSC-182986.
Arm II:  Single-agent Chemotherapy.  Carmustine, BCNU, NSC-409962.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Jane Leiby, MD, Protocol chair		Ph: 614-442-3130