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 70 NCI, NINDS NINDS-83-N-63 NCI-T84-0415N, T84-0415

Objectives

I.  Determine the feasibility of pre-selecting chemotherapeutic agents for 
patients with brain tumors on the basis of tissue culture drug sensitivities.
II.  Compare the results of the administration of aziridinylbenzoquinone, 
CCNU, and cis-platinum in a standard sequence vs. in a sequence based on 
tissue culture drug sensitivities to patients with malignant brain tumors.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 18 to 70 years of age with a 
high likelihood of harboring a malignant brain tumor or with specific clinical 
or radiographic evidence for such a tumor.  Patients with a biopsy-proven 
diagnosis of malignant brain tumor are also eligible.  There must be 
measurable intracranial disease on CT scan.  The life expectancy must be at 
least 8 weeks.  Adequate renal and hepatic function are required; hematologic 
function must be adequate unless there is marrow involvement by tumor.  Prior 
or concurrent systemic chemotherapy is not allowed.  Surgical confirmation of 
a malignant primary brain tumor of glial origin must be obtained; growth of a 
patient's tumor cells in culture is required for entry.

Expected Enrollment

60 patients will be treated.

Outline

All patients are randomized to Arms I and II except those whose tumors are 
shown by in-vitro assay to be resistant to all 3 protocol drugs.  These 
patients may either enter Arm I or elect to enter a Phase I protocol.
Arm I:  Standard Sequential 3-Drug Chemotherapy.  Aziridinylbenzoquinone, AZQ, 
NSC-182986; followed by CCNU, NSC-79037; followed by cis-Platinum, CACP, 
NSC-119875.
Arm II:  Sequential 3-Drug Chemotherapy Determined by In-vitro Assay.  AZQ; 
CCNU; CACP.  Administration in order of effectiveness (most effective first, 
least effective last) determined by in-vitro assays.

Trial Contact Information

Trial Lead Organizations

National Institute of Neurological Disorders and Stroke

Paul Kornblith, MD, Protocol chair(Contact information may not be current)		Ph: 412-432-1512