RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma.

Condition	Treatment or Intervention	Phase
Stage IV Melanoma stage III melanoma Recurrent Melanoma	Drug: gp209-2M antigen  Drug: heat shock protein 70  Drug: OVA BiP peptide  Drug: tyrosinase peptide	Phase I

Further Study Details: 

OBJECTIVES: I. Determine whether active specific immunization comprised of tyrosinase and gp100:209-217 (gp100) peptides fused with OVA BiP peptide and heat shock protein 70 (HSP70) induces immunity against tyrosinase and gp100 in HLA-A2 positive patients with stage III or IV melanoma.

II. Determine the lowest optimally immunogenic dose of tyrosinase and gp100 in these patients.

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

PROTOCOL OUTLINE: This is a dose escalation study of tyrosinase and gp100:209-217 antigen (gp100).

Patients receive vaccination comprised of tyrosinase and gp100 fused with OVA BiP peptide and heat shock protein 70 (HSP70) subcutaneously on weeks 0, 1, 2, 6, and 18 for a total of 5 vaccinations in the absence of disease progression or unacceptable toxicity.

Cohorts of 9 patients receive escalating doses of tyrosinase and gp100 until the lowest optimally immunogenic dose is determined. The lowest optimally immunogenic dose is defined as the dose at which 4 or more of 9 patients demonstrate T-cell responses.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage III or IV melanoma that is in remission for 2-52 weeks after surgical resection OR minimally resectable
• HLA-A2 positive
• Patients who are candidates for potentially curative surgery not eligible until after surgery

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No concurrent chemotherapy
• Endocrine therapy: No corticosteroids during the interval between 1 week prior to each immunization through 2 weeks after each immunization
• Radiotherapy: No concurrent radiotherapy
• Surgery: Not specified
• Other: No antiinflammatory agents (e.g., aspirin) or other nonsteroidal antiinflammatory drugs during the interval between 1 week prior to each immunization through 2 weeks after each immunization

--Patient Characteristics--

• Age: Over 18
• Performance status: Karnofsky 80-100%
• Life expectancy: Not specified
• Hematopoietic: WBC greater than 3,000/mm3; Platelet count greater than 100,000/mm3
• Hepatic: Bilirubin less than 2.5 mg/dL; AST less than 74 Units/L; LDH less than 400 Units/L; Alkaline phosphatase no greater than 1.5 times upper limit of normal
• Renal: Not specified
• Pulmonary: No evidence of disease by chest x-ray or chest CT scan; If pulmonary function tests are abnormal, then abdominal CT scan must be performed
• Other: Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception; No other high risk malignancy within the past 2 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No other medical condition that would preclude compliance or immunologic response; No new metastasis during study that requires chemotherapy or radiotherapy

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Philip O. Livingston,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067788; MSKCC-99036; NCI-G00-1771
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  May 2, 2000
ClinicalTrials.gov Identifier:  NCT00005633
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08