NCT00005617

Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma

A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.

Detailed description

OBJECTIVES: * Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma. * Determine the immunological and clinical responses in this patient population after this therapy. OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28. Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	dendritic cell-MART-1 peptide vaccine	Number DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group.
PROCEDURE	leukapheresis	Patients require a single leukapheresis to obtain 2x10\^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups.

Timeline

• Start date: 1997-07-01
• Primary completion: 2002-06-01
• First posted: 2003-01-27
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States