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

PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.

Condition	Treatment or Intervention	Phase
intraocular melanoma Melanoma	Drug: Montanide ISA-51  Drug: multi-epitope melanoma peptide vaccine  Drug: sargramostim  Procedure: biological response modifier therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: non-specific immune-modulator therapy  Procedure: non-tumor cell derivative vaccine  Procedure: vaccine therapy	Phase I Phase II

Further Study Details: 

OBJECTIVES:

• Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).

OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
• Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
• Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I. On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.

PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage IIIB, IIIC, or IV melanoma
• HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive
• Brain metastases allowed at the discretion of the principle investigator

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 100,000/mm ^3
• Hemoglobin > 9 g/dL

Hepatic

• Liver function tests ≤ 2.5 times upper limit of normal (ULN)

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV heart disease

Other

• Prior diagnosis of other cancer allowed
• Not pregnant or nursing
• Weight ≥ 110 pounds
• No uncontrolled diabetes

PRIOR CONCURRENT THERAPY: Biologic therapy

• More than 4 weeks since prior growth factors
• More than 4 weeks since prior allergy shots
• More than 12 weeks since prior melanoma vaccine therapy* NOTE: *Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine
• No prior vaccination with any of the peptides used in this study

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• More than 1 month since prior investigational drugs or therapies
• No other concurrent investigational drugs or therapies

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting

Study chairs or principal investigators

Craig L. Slingluff, MD,  Study Chair,  University of Virginia, Health Sciences Center Cancer Center   

Study ID Numbers:  CDR0000378171; UVACC-MEL-41; UVACC-28502; UVACC-HIC-10464; NCT00089219
Record last reviewed:  September 2004
Last Updated:  March 15, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00089219
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08