Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma

Phase 2

Terminated

• Conditions: Melanoma (Skin)

• Registration Number: NCT00003715
• Lead Sponsor: AVAX Technologies

Brief Summary

RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with that of interferon alfa-2b in treating patients who have stage III melanoma that has spread to regional lymph nodes following surgery.

Detailed Description

OBJECTIVES: I. Compare the relapse-free and overall survival rates in patients with stage III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient population.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to number of metastatic lymph node sites (1 vs more than 1), number of positive lymph nodes in a single site (none vs 1 or more), presence of intransit metastases (yes vs no), and evidence of extranodal extension (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5 consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3 times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1998-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-04-22
• Study First Posted: 2004-04-23
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 425

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (17)

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

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

Jersey Shore Cancer Center; 🇺🇸 Neptune, New Jersey, United States

Cancer and Blood Institute of the Desert; 🇺🇸 Rancho Mirage, California, United States

Columbia - HCA Cancer Research Network; 🇺🇸 North Miami Beach, Florida, United States

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

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Lutheran General Cancer Care Center; 🇺🇸 Park Ridge, Illinois, United States

Hubert H. Humphrey Cancer Center; 🇺🇸 Robbinsdale, Minnesota, United States

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States

Cancer and Hematology Centers of Western Michigan; 🇺🇸 Grand Rapids, Michigan, United States

Midwest Oncology Consortium; 🇺🇸 Kansas City, Missouri, United States

Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

University of Pennsylvania Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Herbert Irving Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Palmetto Hematology/Oncology Associates; 🇺🇸 Spartanburg, South Carolina, United States