RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response that will kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating white blood cells to kill melanoma cells.

PURPOSE: Randomized phase II trial to determine the effectiveness of vaccine therapy given with interleukin-12 in treating patients who have stage III or stage IV melanoma.

Condition	Treatment or Intervention	Phase
Stage IV Melanoma recurrent intraocular melanoma stage III melanoma Recurrent Melanoma	Drug: gp100 antigen  Drug: interleukin-12  Drug: Montanide ISA-51  Drug: tyrosinase peptide	Phase II

Further Study Details: 

OBJECTIVES: I. Evaluate immune reactivity to tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) with or without interleukin-12 following surgical resection in HLA-A2 positive patients with stage III or IV melanoma.

PROTOCOL OUTLINE: This is a randomized, parallel study. Patients are stratified by prior therapy (immunotherapy or chemotherapy vs surgery only).

Patients are randomized to receive 1 of 2 treatment arms:

Arm I: Following surgery, patients receive tyrosinase and gp100 peptides emulsified with Montanide ISA-51 (ISA-51) subcutaneously (SQ) once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations.

Arm II: Following surgery, patients receive treatment as in Arm I followed by interleukin-12 SQ once weekly during weeks 0, 2, 4, 6, 10, 14, 18, and 26 for a total of 8 vaccinations.

Patients are followed at 2-4 weeks, then every 3 months for 2 years after resection, then every 6 months for 3 years, and then yearly if without evidence of disease.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study over 2 years.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage III or IV cutaneous or ocular melanoma that can be completely resected or rendered free of disease but is at high risk of recurrence OR Recurrent disease following interferon alfa or ineligible for or refused interferon alfa
• HLA-A2 positive
• Tumor tissue must be available for analysis of gp100/tyrosinase expression; Detectable expression of one or the other antigen not required

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; At least 1 month since prior biologic therapy
• Chemotherapy: At least 1 month since prior chemotherapy, including adjuvant therapy
• Endocrine therapy: At least 1 month since prior endocrine therapy; No concurrent steroid therapy
• Radiotherapy: At least 1 month since prior radiotherapy
• Surgery: See Disease Characteristics; At least 1 month since prior surgery

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Absolute granulocyte count at least 1,500/mm3; Hemoglobin at least 9 g/dL
• Hepatic: Bilirubin no greater than 2 mg/dL
• Renal: Creatinine no greater than 2.0 mg/dL; Creatinine clearance at least 60 mL/min
• Cardiovascular: No major cardiovascular illness
• Pulmonary: No major respiratory illness (e.g., pneumonia)
• Gastrointestinal: No major gastrointestinal illness
• Other: Not pregnant or nursing; No major systemic infection (e.g., sepsis); No coagulation or bleeding disorder; HIV negative; Hepatitis B surface antigen negative; Hepatitis C surface antigen negative; No history of uveitis or autoimmune inflammatory eye disease; No active autoimmune disease; Not allergic to Montanide ISA-51; No active second malignancy within the past 5 years

California
      Beckman Research Institute, City of Hope, Duarte,  California,  91010,  United States
      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000066310; LAC-USC-10M973; NCI-G98-1432; NCI-T97-0099
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003339
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08