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.

Condition	Treatment or Intervention	Phase
Stage IV Melanoma Recurrent Melanoma Quality of Life	Drug: Detox  Drug: interferon alfa	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
California
      Beckman Research Institute, City of Hope, Duarte,  California,  91010,  United States
      Kaiser Permanente Medical Center - Oakland, Oakland,  California,  94611,  United States
      Kaiser Permanente Medical Center - Santa Clara, Santa Clara,  California,  95051-5386,  United States
      Kaiser Permanente Medical Center - Vallejo, Vallejo,  California,  94589,  United States
      Kaiser Permanente Medical Center-Sacramento, Sacramento,  California,  95825,  United States
      Kaiser Permanente Medical Group - San Francisco, San Francisco,  California,  94115,  United States
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
      University of California San Diego Cancer Center - La Jolla, La Jolla,  California,  92093-0686,  United States
Connecticut
      University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States
Florida
      Adventist Health System/Sunbelt, Inc., Orlando,  Florida,  32803,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
Georgia
      Emory University School of Medicine, Atlanta,  Georgia,  30322,  United States
Illinois
      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States
Kentucky
      University of Louisville Hospital, Louisville,  Kentucky,  40202,  United States
Nebraska
      Creighton University Cancer Center, Omaha,  Nebraska,  68131-2197,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New Mexico
      University of New Mexico Cancer Research & Treatment Center, Albuquerque,  New Mexico,  87131,  United States
New York
      Interlakes Oncology/Hematology PC, Rochester,  New York,  14623,  United States
North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
Ohio
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States
      CCOP - Columbus, Columbus,  Ohio,  43206,  United States
      Christ Hospital, Cincinnati,  Ohio,  45219,  United States
      Hematology Oncology Consultants Inc, Columbus,  Ohio,  43235,  United States
Oregon
      Oregon Cancer Center at Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States
Texas
      Southwest Regional Cancer Center, Austin,  Texas,  78705,  United States

Study chairs or principal investigators

Kenneth B. Von Eschen,  Study Chair,  RIBI Immunochem Research   

Study ID Numbers:  CDR0000064732; CORIXA-2885-14; RIR-2885-14; NCI-V96-0883; YALE-HIC-8666
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002767
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08