RATIONALE: Vaccines may make the body build an immune response and kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon alfa-2b may interfere with the growth of tumor cells.

PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 with or without interferon alfa-2b in treating patients who have stage III melanoma.

Condition	Treatment or Intervention	Phase
stage III melanoma	Drug: interferon alfa  Drug: interleukin-2 liposome  Drug: polyvalent melanoma vaccine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the effect of interferon alfa-2b on the potentiation of antimelanoma antibodies and cellular immune responses induced by immunization to a polyvalent melanoma vaccine and interleukin-2 in patients with stage III malignant melanoma.

II. Determine the optimal dose of interferon that will maximally stimulate these responses in these patients.

III. Determine the toxicity of this regimen in these patients.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized into a vaccine treated control arm or to receive one of two doses of interferon alfa-2b plus vaccine.

All patients receive polyvalent melanoma vaccine incorporated into interleukin-2 liposomes. The vaccine is administered intradermally every 2 weeks for 8 weeks, monthly for 3 months, and then every 3 months for a total of 2 years or until disease progression.

Patients assigned to arms II or III also receive interferon alfa-2b subcutaneously, at one of two doses, three times a week for 2 years.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 18 months.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven, surgically resected stage III melanoma; Clinically positive nodes AND/OR At least 2 histologically positive nodes
• HLA-A2, A3, A11, or A26 positive
• Intact cellular immunity as evidenced by at least 5 mm reaction at 48 hours to at least 1 of the following recall antigens: PPD; Mumps; Candida; Streptokinase streptodornase OR able to be sensitized to dinitrochlorobenzene

--Prior/Concurrent Therapy--

• Biologic therapy: No prior melanoma vaccine; No prior immunotherapy; No other concurrent immunotherapy
• Chemotherapy: No prior chemotherapy; No concurrent chemotherapy
• Endocrine therapy: At least 2 weeks since prior glucocorticosteroids for nonmalignant purposes; No concurrent steroids
• Radiotherapy: No concurrent radiotherapy
• Surgery: At least 4 weeks (but no more than 12 weeks) since prior major surgery
• Other: No concurrent immunosuppressive drugs

--Patient Characteristics--

• Age: 18 to 75
• Performance status: ECOG 0-2
• Life expectancy: At least 12 months
• Hematopoietic: WBC greater than 3500/mm3; Platelet count greater than 100,000/mm3; Hematocrit greater than 30%
• Hepatic: Bilirubin less than 2.0 mg/dL; SGOT no greater than 2 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2 times ULN; Prothrombin time normal
• Renal: Creatinine less than 2.0 mg/dL
• Cardiovascular: No significant cardiovascular disease; No uncontrolled hypertension; No congestive heart failure; No uncontrolled cardiac arrhythmia; No active angina pectoris; No myocardial infarction in the past 12 months
• Pulmonary:
• Other: No second malignancy except carcinoma in situ of the cervix or basal or squamous cell skin cancer; No autoimmune disease; HIV negative; No significant medical illness that would preclude compliance; At least 4 weeks since prior serious infection requiring antibiotics; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

New York
      Kaplan Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Jean-Claude Bystryn,  Study Chair,  Kaplan Cancer Center   

Study ID Numbers:  CDR0000067323; NYU-9837; NCI-G99-1595
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004104
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08