NCT00022568

Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma

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

Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma. * Determine the clinical toxic effects of this vaccine in these patients. * Determine the safety of this vaccine in these patients. * Determine the clinical response of these patients to this vaccine. * Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine. OUTLINE: This is a dose-escalation study. Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3 vaccinations. Patients with stable or responding disease may receive an additional course of vaccinations. Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine 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. Quality of life is assessed at baseline, at each vaccine administration, and at study completion. Patients are followed at 3 months. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12 months.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	recombinant vaccinia-TRICOM vaccine

Timeline

• Start date: 2001-08-01
• First posted: 2003-01-27
• Last updated: 2013-12-18

Locations

1 site across 1 country: United States