NCT00085488

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

En Vivo Matured Dendritic Cell Therapy in Patients With Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	autologous tumor cell vaccine
BIOLOGICAL	therapeutic autologous dendritic cells

Timeline

• Start date: 2004-02-01
• Primary completion: 2006-02-01
• Completion: 2006-02-01
• First posted: 2004-06-11
• Last updated: 2015-02-02

Locations

1 site across 1 country: United States