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

NCT00002767 | Unknown Phase 3

• 5 other identifiers: CDR0000064732CORIXA-2885-14RIR-2885-14YALE-HIC-8666NCI-V96-0883
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

Detox-B adjuvant BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (27)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Beckman Research Institute, City of Hope

Duarte, California, 91010, United States

Location

University of California San Diego Cancer Center - La Jolla

La Jolla, California, 92093-0686, United States

Location

Kaiser Permanente Medical Center - Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente Medical Center-Sacramento

Sacramento, California, 95825, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Kaiser Permanente Medical Group - San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051-5386, United States

Location

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, 94589, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Adventist Health System/Sunbelt, Inc.

Orlando, Florida, 32803, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Creighton University Cancer Center

Omaha, Nebraska, 68131-2197, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

University of New Mexico Cancer Research & Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45219, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

CCOP - Columbus

Columbus, Ohio, 43206, United States

Location

Hematology Oncology Consultants Inc

Columbus, Ohio, 43235, United States

Location

Oregon Cancer Center at Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

detox adjuvant; Interferon-alpha

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Kenneth B. Von Eschen, PhD

  GlaxoSmithKline

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 2, 2004
• Study Start: January 1, 1996
• Last Updated: January 6, 2014

Record last verified: 2007-05

Locations

US (27)