Melanoma (Skin) Clinical Trial
Official title:
Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
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.
;
Primary Purpose: Treatment
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