Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

Phase 3

Completed

• Conditions: Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma

• Registration Number: NCT00003647
• Lead Sponsor: Vical

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.

Detailed Description

OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.

II. Determine the benefits, risks, and side effects of these regimens in this patient population.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.

Patients with stable or responding disease may receive additional courses every 28 days.

Patients are followed every 4 months.

PROJECTED ACCRUAL:

A total of 280 patients (140 in each arm) will be accrued for this study.

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 1999-11-01
• Study Completion: 2002-09
• Study First Submitted QC: 2004-03-22
• Study First Posted: 2004-03-23
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-23
• Last Update Posted: 2008-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (44)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Comprehensive Blood and Cancer Center; 🇺🇸 Bakersfield, California, United States

Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas; 🇺🇸 Encinitas, California, United States

Kaiser Permanente-Southern California Permanente Medical Group; 🇺🇸 San Diego, California, United States

Yale Comprehensive Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Washington Cancer Institute; 🇺🇸 Washington, District of Columbia, United States

Mount Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Georgia Cancer Specialists; 🇺🇸 Decatur, Georgia, United States

Georgia Cancer Specialists, P.C.; 🇺🇸 East Point, Georgia, United States

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