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 Closed 18 to 80 OSP-84234 NCI-V85-0081

Objectives

I.  Compare survival produced by diaziquone vs. 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 diaziquone 
vs. carmustine in this patient population.
III.  Compare the tolerance and toxicity of diaziquone and carmustine in this 
patient population.

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 of greater than 1,500 and 150,000/cumm, 
respectively.  A life expectancy of at least 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 illness (e.g., dementia, multiple sclerosis, 
and 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

University of Texas Medical Branch

John Costanzi, MD, Protocol chair		Ph: 512-343-2103 Email: drjjjc@aol.com