Decitabine in Treating Patients With Advanced Refractory Solid Tumors or Lymphomas

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00089089
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Terminated
• Phase: Phase 1
• Start date: September 2004