Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00022568
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.
Study:
NCT00022568
Study Brief:
Protocol Section:
NCT00022568