Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: Chemotherapy in Treating Patients With Advanced Solid Tumors

Official Title: A Phase I Study of Cyclic Oral Administration of SCH 52365 for 21 of 28 Days in Patients With Advanced Solid Malignancies

Study ID: NCT00003708

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

temozolomide

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of temozolomide in treating patients who have advanced solid tumors.

Detailed Description: OBJECTIVES: I. Determine the safety, tolerability, maximum tolerated dose, and dose limiting toxicity of temozolomide in patients with advanced solid malignancies. II. Characterize the single- and multiple-dose pharmacokinetics of temozolomide following oral administration in these patients. III. Determine antitumor activity of temozolomide in these patients. OUTLINE: This is an open label, dose escalation study. Patients receive oral temozolomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at escalating doses of temozolomide. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT) during courses 1 or 2, with at least 2 patients experiencing DLT at the next higher dose level. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.