Melanoma Clinical Trial
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Dallas Texas, 75246, United States
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