NCT00004025

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma

Phase I/II Trial of the Safety, Immunogenicity, and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 (rIL-2) in Patients With Stage IV Melanoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from a person's white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for stage III or stage IV melanoma. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed.

Detailed description

OBJECTIVES: I. Evaluate the safety, dose-limiting toxicity, and maximum tolerated dose of autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma. II. Evaluate the cellular response and efficacy of these regimens in this patient population. OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to one of three dose levels. Patients receive modified autologous dendritic cells subcutaneously on day 1 with or without interleukin-2 IV on days 4-19. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of modified dendritic cells with or without interleukin-2 until the maximum tolerated dose (MTD) for each regimen is reached. The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study within 1 year.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	dendritic cell-gp100-MART-1 antigen vaccine

Timeline

• Start date: 1999-03-01
• First posted: 2003-10-29
• Last updated: 2014-01-06

Locations

2 sites across 1 country: United States