Vaccine Therapy in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00022568|
Recruitment Status : Unknown
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: recombinant vaccinia-TRICOM vaccine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma|
|Study Start Date :||August 2001|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|