Vaccine Therapy in Treating Patients With Metastatic Melanoma

Baylor Health Care System

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Melanoma (Skin)

Interventions

filgrastimBIOLOGICAL

therapeutic autologous dendritic cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Data from ClinicalTrials.gov

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