RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF may increase the number of immune cells found in the bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with GM-CSF and interleukin-2 may be kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccines made from melanoma cells with or without GM-CSF followed by interleukin-2 in treating patients with stage III or stage IV melanoma.

Condition	Treatment or Intervention	Phase
stage III melanoma Stage IV Melanoma Recurrent Melanoma	Procedure: biological response modifier therapy  Procedure: non-specific immune-modulator therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Procedure: interleukin therapy  Vaccine: non-tumor cell derivative vaccine  Procedure: vaccine therapy  Drug: gp100 antigen  Drug: interleukin-2  Drug: Montanide ISA-51  Drug: sargramostim  Drug: tetanus peptide melanoma vaccine  Drug: tyrosinase peptide	Phase II

Further Study Details: 

OBJECTIVES: I. Compare the effectiveness of vaccination with synthetic melanoma peptides pulsed on autologous dendritic cells versus vaccination with synthetic melanoma peptides plus sargramostim (GM-CSF) in decreasing tumor burden in patients with high risk melanoma (pulsed autologous dendritic cell arm closed 1/8/2001). II. Determine whether these regimens result in increased tumor specific immune responses as measured in vitro and in vivo. III. Determine whether these regimens stimulate T-cell responses in these patients.

PROTOCOL OUTLINE: This is an open label study. Patients are included in treatment arm II only (arm I closed 1/8/2001): Arm I: Patients undergo leukapheresis to collect dendritic cells. Patients receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus peptides) pulsed on autologous dendritic cells IV and subcutaneously (SC). Arm II: Patients receive a mixture of synthetic melanoma peptides (gp100 antigen, tyrosinase, and tetanus peptides) and sargramostim (GM-CSF) emulsified in Montanide ISA-51 SC and intradermally. Patients receive vaccination during weeks 0, 1, 2, 4, 5, and 6 for a total of 6 doses and interleukin-2 SC daily on days 7-49. Patients receive 3 additional vaccinations at different sites not involved with the tumor concurrently with the first 3 vaccinations. Patients are evaluated at 8 weeks, 12 weeks, 6 months, 12 months, and 24 months.

PROJECTED ACCRUAL: A total of 27-54 patients will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years   -   79 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed stage III or IV melanoma; gp100 positive tumor cells and/or tyrosinase positive tumor cells
• HLA type A1, A2, or A3
• Measurable disease
• May have up to 3 brain metastases if all are less than 2 cm in diameter and are asymptomatic, and there is no mass effect or they have been treated successfully by surgical excision or by gamma knife radiation therapy

--Prior/Concurrent Therapy--

• Biologic therapy: At least 3 months since prior growth factors; At least 3 months since prior agents with putative immunomodulating activity (except nonsteroidal antiinflammatory agents); At least 1 year since other prior melanoma vaccinations
• Chemotherapy: At least 3 months since prior chemotherapy; No concurrent chemotherapy
• Endocrine therapy: At least 3 months since prior corticosteroids; No concurrent corticosteroids
• Radiotherapy: At least 3 months since prior radiotherapy; No concurrent radiotherapy
• Surgery: See Disease Characteristics
• Other: At least 3 months since other prior investigational drugs or therapy; At least 3 months since prior allergy desensitization injections; At least 14 days since completion of acute treatment for a serious infection; No concurrent allergy desensitization injections

--Patient Characteristics--

• Age: 18 to 79
• Performance status: ECOG 0-1
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 1,000/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL
• Hepatic: Bilirubin no greater than 2.5 times upper limit of normal (ULN); AST and ALT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN
• Renal: Creatinine no greater than 1.5 times ULN
• Cardiovascular: No New York Heart Association class II, III, or IV heart disease
• Other: No known or suspected allergy to any component of the vaccine; No medical condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

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

Study chairs or principal investigators

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

Study ID Numbers:  CDR0000066084; UVACC-HIC-7621; NCI-G98-1389; UVA-HIC-7621
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003222
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08