Vaccine Therapy in Treating Patients With Metastatic Melanoma
Recruitment status was: Active, not recruiting
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.
|Melanoma (Skin)||Biological: filgrastim Biological: therapeutic autologous dendritic cells||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial|
|Study Start Date:||April 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017355
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Study Chair:||Joseph W. Fay, MD||Baylor Health Care System|