Decitabine in Treating Patients With Melanoma or Other Advanced Cancer

Lymphoma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precancerous Condition
• Precancerous Conditions
• Preleukemia
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00002980
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 1
• Start date: May 1997