NCT00004148

Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma

A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma. II. Determine all clinical toxicities associated with this regimen in this patient population. III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen. V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen. VII. Evaluate quality of life of these patients during this regimen. OUTLINE: This is a dose escalation study. Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities. Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	recombinant vaccinia-B7.1 vaccine

Timeline

• Start date: 1999-10-01
• Primary completion: 2006-04-01
• First posted: 2004-02-20
• Last updated: 2013-02-11

Locations

1 site across 1 country: United States