Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
RATIONALE: Vaccines made from a patient's dendritic cells and tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage III or stage IV melanoma.
|Melanoma (Skin)||Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma|
- Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma [ Time Frame: 2005-2006 ]
|Study Start Date:||February 2004|
|Study Completion Date:||February 2006|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- Determine the dose-limiting toxicity and the maximum tolerated dose of autologous dendritic cells pulsed with autologous tumor cell lysate in patients with stage III or IV melanoma.
- Determine the safety and tolerability of this therapy in these patients.
- Determine the immune response, in terms of the type and degree of T-cell proliferation and delayed-type hypersensitivity responses, in patients treated with this therapy.
OUTLINE: This is a dose-escalation, pilot study.
Patients undergo leukapheresis for the collection of peripheral blood mononuclear cells (PBMC) on days -9, 19, and 47. Autologous dendritic cells (DC) are prepared from autologous PBMC exposed to sargramostim (GM-CSF), interleukin-4, and tumor necrosis factor alpha and pulsed with autologous tumor cell lysate. Patients receive autologous tumor cell lysate-pulsed DC IV over 5-10 minutes on days 0, 28, and 56.
Cohorts of 3-6 patients receive escalating doses of autologous tumor cell lysate-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of all patients experience dose-limiting toxicity.
Patients are followed at day 84 and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 3-20 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085488
|United States, New Hampshire|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Christopher P. Tretter, MD||Norris Cotton Cancer Center|