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

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Trial Identification

Brief Title: Decitabine in Treating Patients With Advanced Solid Tumors

Official Title: A Phase I Study Of The Toxicities, Biologic And Clinical Effects Of Daily 5 Aza 2'Deoxycytidine (DAC), NSC 127716 (IND 50733) For Four Weeks In Patients With Advanced Malignancies

Study ID: NCT00030615

Conditions

Male Breast Cancer

Recurrent Bladder Cancer

Recurrent Breast Cancer

Recurrent Melanoma

Stage III Melanoma

Stage IV Bladder Cancer

Stage IV Breast Cancer

Stage IV Melanoma

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

decitabine

pharmacological study

laboratory biomarker analysis

Study Description

Brief Summary: This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description: PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors. II. Determine the toxic effects of this drug in these patients. III. Determine the dose of this drug with biologic activity in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine clinical response to this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks.