Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Study of Prolonged Low Dose Decitabine (5-Aza-Deoxycytidine, NSC #127716) in Patients With Biopsiable Advanced Cancers Refractory to Standard Therapy
This phase I trial is studying the side effects and best dose of decitabine in treating patients with metastatic or unresectable refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose of single agent decitabine and its toxicity using
this schedule in this population of patients with solid tumors or lymphomas.
II. Definition of the dose at which tumor DNA demethylation is optimum. III. Definition of
the dose at which peripheral blood mononuclear cell (PBMN) demethylation is optimal.
IV. Definition of decitabine pharmacokinetics and correlation of plasma concentrations with
hypomethylation effects.
SECONDARY OBJECTIVES:
I. Preliminary assessment of decitabine efficacy (objective response).
OUTLINE: This is a dose-escalation study.
Patients receive decitabine IV over 1 hour on days 1-5 or on days 1-5 and 8-12. Courses
repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 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 2 of 6
patients experience dose-limiting toxicity.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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