Vaccine Therapy in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Detailed Description
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OBJECTIVES: Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma. Determine the longevity of melanoma-specific immunity in patients treated with this regimen. Perform serial analysis of T-cell and B-cell function in patients treated with this regimen. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation. Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression. Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Official Title
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Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: filgrastim
* Biological: therapeutic autologous dendritic cells


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma HLA-A2-01 phenotype Measurable disease No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics No viral hepatitis Renal: Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive heart failure Lactate dehydrogenase less than 2 times normal Pulmonary: No prior asthma Immunologic: Intradermal skin test positivity to mumps, Candida, or streptokinase antigen No known sensitivity to E. coli drug preparations No prior allergy to influenza vaccine No active infection No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior interleukin-2 At least 4 weeks since prior interferon alfa Chemotherapy: At least 8 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent immunosuppressive agents At least 2 weeks since prior immunosuppressive agents

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Biological: therapeutic autologous dendritic cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma