NCT00019890

Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma

Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 16 Years
• Healthy volunteers: —

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.

Detailed description

OBJECTIVES: I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma. PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived either from peripheral monocytes or CD34+ cells. Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion, and are administered intralymphatically in the lower extremities for the first 2 courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in the anterior thigh. Dendritic cells are not administered to any extremity that has undergone lymph node dissection. Patients are randomized to the following treatment arms: Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses. Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses. Patients are followed at 4 to 6 weeks. PROJECTED ACCRUAL: A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7 months.

Conditions

• Stage IV Melanoma
• Stage III Melanoma
• Recurrent Melanoma

Interventions

Type	Name	Description
DRUG	dendritic cell-gp100-MART-1 antigen vaccine
DRUG	sargramostim

Timeline

• Completion: 2007-03-01
• First posted: 2007-03-05
• Last updated: 2024-03-04