RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase / gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.

Condition	Treatment or Intervention	Phase
stage II melanoma	Drug: gp100 antigen  Drug: Montanide ISA-51  Drug: sargramostim  Drug: tyrosinase peptide	Phase II

Further Study Details: 

OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprised of tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF).

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive vaccine comprised of tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within 3 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage IIA or stage IIB resectable cutaneous melanoma rendered disease free
• Clinically uninvolved lymph nodes by physical examination OR Pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete node dissection or selective lymphadenectomy, respectively
• No evidence of metastatic disease within 28 days prior to definitive surgery
• HLA-A2 positive

--Prior/Concurrent Therapy--

• At least 1 month since prior adjuvant therapy or any other therapy for cancer
• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: No concurrent steroid therapy
• Radiotherapy: At least 1 month since prior radiotherapy
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Hematopoietic: No coagulation disorders; No significant hematologic abnormality
• Hepatic: Bilirubin no greater than 2.0 mg/dL; No significant liver abnormality
• Renal: Creatinine no greater than 2.0 mg/dL; No significant kidney abnormality
• Cardiovascular: No major medical illness of the cardiovascular system
• Pulmonary: No major medical illness of the respiratory system
• Other: No known allergic reaction to Montanide ISA-51 or sargramostim (GM-CSF); No major systemic infections; Not pregnant or nursing; HIV negative; Hepatitis B surface antigen negative; Hepatitis C antibody negative; No prior uveitis or autoimmune inflammatory eye disease; No active autoimmune disease; No other malignancy within past 5 years

California
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States

Study chairs or principal investigators

Jeffrey S. Weber,  Study Chair,  University of Southern California   

Study ID Numbers:  CDR0000066176; LAC-USC-10M971; NCI-T97-0100; LAC-USC-FDR001101
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003274
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08