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 no age specified MAOP-8182

Objectives

I.  Determine the rate and duration of response to therapy with 
aziridinylbenzoquinone in patients with malignant primary tumors of the 
central nervous system.
II.  Determine the rate and duration of response to therapy with carmustine 
(BCNU) in patients with malignant primary tumors of the central nervous system.
III.  Compare the efficacy of aziridinylbenzoquinone to the efficacy of BCNU.
IV.  Compare the tolerance and toxicity of both drugs.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
Grade III/IV astrocytoma (glioblastoma multiforme) who have failed surgery 
and/or radiotherapy or who are not considered candidates for surgery or 
radiotherapy; measurable disease is required.  Patients must have an expected 
survival of over 4 weeks and adequate hematologic, renal, and hepatic 
function.  Prior chemotherapy is not allowed; there must be no radiotherapy 
during the 6 weeks prior to entry (unless there is evidence of tumor 
progression documented on CAT scan after radiotherapy).  Patients with other 
neurologic illness that would obscure evaluation of therapy are not eligible.

Expected Enrollment

110 patients per arm will be required.

Outline

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

Trial Contact Information

Trial Lead Organizations

Mid-Atlantic Oncology Program

Richard Kaplan, MD, Protocol chair(Contact information may not be current)		Ph: 301-496-2522 Email: kaplanr@ctep.nci.nih.gov