Vaccine Therapy in Treating Patients With Metastatic Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00022568
- Lead Sponsor
- Herbert Irving Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States