Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022568
Status:
UNKNOWN
Last Update Posted:
2013-12-18
First Post:
2001-08-10
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-3353 | None | None | None |
| CPMC-IRB-14387 | None | None | None |
| AECM-01-003 | None | None | None |