Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
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
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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