Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
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|ClinicalTrials.gov Identifier: NCT00085488|
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : February 2, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2006|
- Ex Vivo Matured Dendritic Cell Therapy in Patients with Melanoma [ Time Frame: 2005-2006 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|