Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00002767
• Other study ID #: CDR0000064732
• Secondary ID: CORIXA-2885-14RI
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: January 3, 2014
• Start date: January 1996

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.

Description:

OBJECTIVES: I. Compare survival following immunotherapy with an allogeneic melanoma vaccine plus interferon alfa-2b (IFN-A) vs. IFN-A alone in patients with metastatic melanoma. II. Assess the safety and toxicity of immunotherapy with an allogeneic melanoma vaccine plus IFN-A in these patients. III. Compare the frequencies of durable complete responses in each treatment group. IV. Compare overall clinical objective response, duration of response, and time to disease progression in each treatment group. V. Compare the effects of immunotherapy with an allogeneic melanoma vaccine plus IFN-A vs IFN-A alone on quality of life in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by location of metastatic sites (visceral and bone vs nonvisceral and lung) and number of metastatic sites (1 vs 2 vs 3 or more). Patients are randomized to one of two treatment arms. Arm I: Patients receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously (SQ) weekly on weeks 1-5 and 8-12. Interferon alfa (IFN-A) SQ is administered three times a week beginning on week 4. Patients with responding or stable disease receive vaccine monthly beginning on week 16. IFN-A continues in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive IFN-A SQ three times a week beginning on week 1. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before, during, and after treatment. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 300 patients will be entered over 2 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma that is metastatic (any pT, any N, M1 by AJCC staging) Measurable disease by physical exam or noninvasive radiologic procedure No concurrent or prior diagnosis of ocular melanoma No CNS metastases No patients who can be rendered NED by surgery unless patient declines surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:

At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times normal No evidence of hepatic failure No active hepatitis Renal: Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction within 6 months No decompensating congestive heart failure No unstable angina No current symptomatic arrhythmia Other: No known HIV antibody No thyroid abnormality uncontrollable by medication No medical, sociological, or psychological impediment to study compliance No pre-existing psychiatric condition (especially depression) or history of severe psychiatric disorder No autoimmune disease (e.g., systemic lupus erythematosus, multiple sclerosis, ankylosing spondylitis) No concurrent malignancy except nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test Effective contraception required of fertile women No history of egg allergies

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since interferon alfa or melanoma vaccine No prior immunotherapy for metastatic disease No concurrent cytokines or levamisole Chemotherapy: No prior chemotherapy for metastatic disease At least 4 months since adjuvant therapy No concurrent chemotherapy Endocrine therapy: At least 1 week since corticosteroids No concurrent immunosuppressives (e.g., azathioprine or cyclosporine) Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• Detox-B adjuvant

• recombinant interferon alfa

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Research & Treatment Center	Albuquerque	New Mexico
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Southwest Regional Cancer Center	Austin	Texas
United States	University of Alabama Comprehensive Cancer Center	Birmingham	Alabama
United States	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio
United States	Christ Hospital	Cincinnati	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Hematology Oncology Consultants Inc	Columbus	Ohio
United States	Beckman Research Institute, City of Hope	Duarte	California
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of California San Diego Cancer Center - La Jolla	La Jolla	California
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	University of Louisville Hospital	Louisville	Kentucky
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Kaiser Permanente Medical Center - Oakland	Oakland	California
United States	Creighton University Cancer Center	Omaha	Nebraska
United States	Adventist Health System/Sunbelt, Inc.	Orlando	Florida
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Oregon Cancer Center at Oregon Health Sciences University	Portland	Oregon
United States	Interlakes Oncology/Hematology PC	Rochester	New York
United States	Kaiser Permanente Medical Center-Sacramento	Sacramento	California
United States	Kaiser Permanente Medical Group - San Francisco	San Francisco	California
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Kaiser Permanente Medical Center - Vallejo	Vallejo	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States,