Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Peptide Vaccine, Montanide ISA 51 and ISA 51 VG, and CpG 7909 in Treating Patients With Resected Stage IIC, Stage III, or Stage IV Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	16 and over	NCI	LAC-USC-10M033 LAC-USC-IRB-942010, NCI-6451, 6451, NCT00085189

Objectives

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

Entry 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

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

Patient Characteristics:

Age

• 16 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³
• 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 and ISA 51 VG
• 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

Expected Enrollment

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

Outcomes

Immunological response as measured by ELISPOT assy, tetramer assay, and chromium release assay

Toxicity
Time to relapse

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 ISA 51 VG, 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.

Trial Contact Information

Trial Lead Organizations

USC/Norris Comprehensive Cancer Center and Hospital

Jeffrey Weber, MD, PhD, Principal investigator(Contact information may not be current)		Ph: 323-865-3962; 800-865-0102 Email: jweber@usc.edu

Registry Information
Official Title		A Phase II Trial of a Vaccine Combining Multiple Class I Peptides with Montanide ISA 51 and ISA 51 VG and CpG Adjuvant 7909 for Patients with Resected Stages IIC/III and IV Melanoma
Trial Start Date		2004-05-28
Trial Completion Date		2007-09-19
Registered in ClinicalTrials.gov		NCT00085189
Date Submitted to PDQ		2004-04-21
Information Last Verified		2005-12-21
NCI Grant/Contract Number		P30-CA14089