Clinical Trials Directory

Trials / Completed

CompletedNCT00002980

Decitabine in Treating Patients With Melanoma or Other Advanced Cancer

A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
—
Sponsor
California Cancer Consortium · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.

Detailed description

OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC. OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased. PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Conditions

Interventions

TypeNameDescription
DRUGdecitabine

Timeline

Start date
1997-05-01
First posted
2004-09-03
Last updated
2013-02-15

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00002980. Inclusion in this directory is not an endorsement.