Trials / Unknown
UnknownNCT00017355
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Baylor Health Care System · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | filgrastim | |
| BIOLOGICAL | therapeutic autologous dendritic cells |
Timeline
- Start date
- 2001-04-01
- First posted
- 2003-01-27
- Last updated
- 2013-09-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00017355. Inclusion in this directory is not an endorsement.