Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

Phase 1

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00398450
• Lead Sponsor: University of California, San Diego

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.

PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.

* Determine if the MTD of this regimen is biologically active in these patients.

* Define and describe the toxicities associated with this regimen.

Secondary

* Determine, preliminarily, the response in patients treated with this regimen.

* Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a dose-escalation study of azacitidine.

Patients receive azacitidine subcutaneously (SC) once daily on days 1-5 (week 1) followed by interferon alfa-2b SC 3 days a week in weeks 2-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-11-09
• Study First Submitted QC: 2006-11-09
• Study First Posted: 2006-11-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose
Toxicity

Secondary Outcome Measures

Name	Time	Method
Response
Relapse-free survival
Survival at day 1, 12 months, 3 years, and 5 years
Time to relapse

Trial Locations

Locations (1)

Rebecca and John Moores UCSD Cancer Center; 🇺🇸 La Jolla, California, United States