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
Overview
- Phase
- Phase 1
- Intervention
- decitabine
- Conditions
- Male Breast Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:
- •Stage III or IV melanoma
- •Mucosal melanoma allowed
- •No resectable stage III melanoma
- •Bladder cancer
- •Breast cancer
- •No active symptomatic CNS disease
- •No radiographically evident cerebral edema
- •Hormone receptor status:
- •Not specified
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (decitabine)
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 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.
Intervention: decitabine
Treatment (decitabine)
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 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.
Intervention: pharmacological study
Treatment (decitabine)
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 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.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
Time Frame: 6 weeks