NCT00039325

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

A Phase I/II Trial Testing Mart-1 Genetic Immunization In Malignant Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in treating patients with stage IV or recurrent malignant melanoma.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	dendritic cell-MART-1 peptide vaccine	Subjects will receive MART-1 adenovirus-transduced dendritic cells (DC)at dose of 10\^6 (for arm A) or 10\^7 (for arms B-E). Subjects will receive a total of three biweekly vaccinations given intradermally. If significant clinical or immunological response (to be defined later) is noted, subjects will be eligible for up to 6 additional monthly vaccine administrations.

Timeline

• Start date: 2002-03-01
• Primary completion: 2005-09-01
• Completion: 2009-06-01
• First posted: 2003-01-27
• Last updated: 2020-08-03

Locations

1 site across 1 country: United States