Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in
treating patients who have recurrent primary malignant glioma.
OBJECTIVES:
- Determine the maximum tolerated dose of irinotecan administered in combination with
temozolomide in patients with recurrent primary malignant glioma.
- Determine the toxicity of this combination therapy in these patients.
OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to
concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or
none).
Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral
temozolomide on days 1-5. Treatment continues every 43 days in the absence of disease
progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose limiting toxicities.
PROJECTED ACCRUAL: Not specified
;
Primary Purpose: Treatment
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