A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
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.
Interventional
Primary Purpose: Treatment
Howard L. Kaufman, MD
Study Chair
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
CDR0000068831
NCT00022568
August 2001
Name | Location |
---|---|
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |