RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining a vaccine with Montanide ISA-51 and CpG 7909 may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining a peptide vaccine with Montanide ISA 51 and CpG 7909 in treating patients who have stage IIC, stage III, or stage IV melanoma that has been completely resected.

Condition	Treatment or Intervention	Phase
stage II melanoma stage III melanoma Stage IV Melanoma iris melanoma ciliary body and choroid melanoma, medium/large size extraocular extension melanoma	Drug: CpG 7909  Drug: MAGE-3  Drug: Montanide ISA-51  Drug: gp100 antigen  Drug: tyrosinase peptide  Procedure: adjuvant therapy  Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the safety and tolerability of a multipeptide (gp100 antigen, MAGE-3, and tyrosinase peptide) melanoma vaccine, Montanide ISA 51, and CpG 7909 in patients with resected stage IIC, III, or IV melanoma.
• Determine the immune reactivity of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to class I haplotype (HLA-A1 vs HLA-A3/A11).

Patients receive gp100 antigen, MAGE-3, tyrosinase peptide, Montanide ISA 51, and CpG 7909 subcutaneously on weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 26, 38, 50, and then every 6 months for 2 years (for a total of 16 vaccinations) in the absence of unacceptable toxicity.

Patients are followed every 6 months for 3 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 42 patients (21 per stratum) will be accrued for this study within 1-2 years.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma
• Stage IIC, III, or IV cutaneous or mucosal disease
• Stage III or IV ocular disease
• Completely resected disease
• Disease-free within the past year after radiotherapy or systemic chemotherapy and/or immunotherapy
• Must be HLA-A1 or -A3/A11 positive by standard DNA-polymerase chain reaction assay AND HLA-B44 status known
• Patients who are B44-positive but do not express A1, A3, or A11 are not eligible
• Positive for gp100 and/or tyrosinase antigen by immunohistochemistry
• Meets 1 of the following conditions for interferon alfa (IFN-α) therapy:
• Failed prior IFN-α therapy
• IFN-α contraindicated due to pre-existing medical or psychiatric condition
• Refused IFN-α treatment

PATIENT CHARACTERISTICS: Age

• 16 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• No coagulation or bleeding disorders

Hepatic

• SGOT and SGPT ≤ 2.5 times normal
• Bilirubin ≤ 2.0 mg/dL
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No major medical illness of the cardiovascular system

Pulmonary

• No pneumonia
• No other major medical illness of the respiratory system

Immunologic

• HIV negative
• No sepsis
• No history of uveitis
• No major systemic infection
• No known allergic reaction to Montanide ISA 51
• No autoimmune inflammatory eye disease
• No other autoimmune disease except vitiligo or controlled thyroiditis

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No major medical illness of the gastrointestinal system
• No other malignancy within the past 3 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy

• See Disease Characteristics
• No prior gp100 antigen, MAGE-3, or tyrosinase peptide

Chemotherapy

• See Disease Characteristics
• More than 6 weeks since prior nitrosoureas

Endocrine therapy

• More than 4 weeks since prior steroid therapy
• No concurrent steroid therapy

Radiotherapy

• See Disease Characteristics
• More than 1 month since prior radiotherapy

Surgery

• See Disease Characteristics

Other

• More than 1 month since prior anticancer therapy
• More than 1 month since prior adjuvant therapy
• No other concurrent anticancer therapy

California
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90089,  United States; Recruiting

Study chairs or principal investigators

Jeffrey S. Weber, MD, PhD,  Principal Investigator,  University of Southern California   

Study ID Numbers:  CDR0000367485; LAC-USC-10M033; LAC-USC-IRB-942010; NCI-6451; NCT00085189
Record last reviewed:  May 2004
Last Updated:  December 6, 2004
Record first received:  June 10, 2004
ClinicalTrials.gov Identifier:  NCT00085189
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08