Vaccine Therapy in Treating Patients With Metastatic Melanoma
Recruitment status was: Active, not recruiting
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.
Biological: recombinant vaccinia-TRICOM vaccine
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma|
|Study Start Date:||August 2001|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022568
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||Howard L. Kaufman, MD||Herbert Irving Comprehensive Cancer Center|