Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma.
Biological: recombinant CD40-ligand
Biological: therapeutic autologous dendritic cells
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination Of HLA-A1 And/Or -A2+ Stage III or IV Melanoma Patients With Tumor Peptide - Loaded Autologous Dendritic Cells That Are Generated In The Absence Or Presence Of CD40 Ligand|
- Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Tolerability [ Designated as safety issue: Yes ]
- Tumor response [ Designated as safety issue: No ]
- Recurrence rates [ Designated as safety issue: No ]
|Study Start Date:||October 2002|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
- Compare the efficacy of vaccination with autologous dendritic cells pulsed with tumor and influenza antigen peptides treated with vs without ex vivo CD40-ligand, in terms of tumor-specific T-cell response, in patients with HLA-A1 and/or HLA-A2.1 positive stage III or IV melanoma.
- Determine the safety and tolerability of these vaccinations in these patients.
- Determine tumor response and recurrence rates in patients treated with these vaccinations.
OUTLINE: This is an open-label non-randomized study.
- Phase I: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DCs) on day -9. DCs are pulsed separately with HLA-A1 and HLA-A2.1-restricted flu matrix peptides derived from melanoma-associated tumor antigens (MAGE-10.A2, Melan-A, MAGE-3, NY-ESO-1, gp100 antigen, and tyrosinase peptide). Half of the DCs are treated ex vivo with CD40-ligand. Patients receive the peptide-pulsed DC vaccinations subcutaneously (SC) on days 1, 14, 42, and 70 in the absence of disease progression.
Patients who show tumor response (at least stable disease) at day 98 progress to phase II of the study.
- Phase II: Patients undergo leukapheresis as in phase I on days 102, 352, and 688. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 126, 184, 268, 356, 520, and 692.
Patients are followed for 10 years.
PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00053391
|Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen|
|Erlangen, Germany, D-91052|
|Study Chair:||Gerold Schuler||Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen|