Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010309
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2001-02-02
Brief Title:
Vaccine Therapy in Treating Patients Who Have Stage II Stage III or Stage IV Melanoma
Sponsor:
Genzyme a Sanofi Company
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial Investigating The Safety And Immunogenicity Of Adenoviruses Encoding The Melan-AMART-1 And gp 100 Melanoma Antigens Administered Intradermally To Patients With Stage II-IV Melanoma
Status:
UNKNOWN
Status Verified Date:
2002-07
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 III trial to study the effectiveness of vaccine therapy in treating patients who have stage II stage III or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage II stage III or stage IV melanoma
Detailed Description:
OBJECTIVES I Determine the safety and the maximum tolerated dose of vaccines containing two adenoviral vectors encoding the melanoma antigens Melan-AMART-1 and gp100 in patients with stage II-IV melanoma II Assess the dose-response changes in the frequency of MART-1 and gp100 reactive T cells CD4 and CD8 in patients receiving one of three different vaccine regimens III Assess the T-cell response to one melanoma antigen following three treatments with the other antigen in these patients IV Assess the effect of concomitant vaccination with both antigens on T-cell response in these patients
OUTLINE This is a dose escalation study Patients are sequentially enrolled on 1 of 3 treatment arms Each treatment arm has 3 groups Arm I Patients receive Ad2MART-1v2 vaccine and Ad2gp100v2 vaccine intradermally ID at the lowest dose level once every three weeks for either 6 or 15 weeks depending on assignment Arm II Patients receive Ad2gp100v2 vaccine and Ad2MART-1v2 vaccine ID at the mid-range dose level once every three weeks for either 6 or 15 weeks depending on assignment Arm III Patients receive Ad2MART-1v2 vaccine and Ad2gp100v2 vaccine ID at the highest dose level once every three weeks for either 6 or 15 weeks depending on assignment Cohorts of 3-6 patients receive escalating doses of Ad2MART-1v2 andor Ad2gp100v2 vaccines in each arm until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed at 3 months 6 months and 1 year after completion of treatment
PROJECTED ACCRUAL A total of 24-36 patients will be accrued over 1 year
OUTLINE This is a dose escalation study Patients are sequentially enrolled on 1 of 3 treatment arms Each treatment arm has 3 groups Arm I Patients receive Ad2MART-1v2 vaccine and Ad2gp100v2 vaccine intradermally ID at the lowest dose level once every three weeks for either 6 or 15 weeks depending on assignment Arm II Patients receive Ad2gp100v2 vaccine and Ad2MART-1v2 vaccine ID at the mid-range dose level once every three weeks for either 6 or 15 weeks depending on assignment Arm III Patients receive Ad2MART-1v2 vaccine and Ad2gp100v2 vaccine ID at the highest dose level once every three weeks for either 6 or 15 weeks depending on assignment Cohorts of 3-6 patients receive escalating doses of Ad2MART-1v2 andor Ad2gp100v2 vaccines in each arm until the maximum tolerated dose MTD is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Patients are followed at 3 months 6 months and 1 year after completion of treatment
PROJECTED ACCRUAL A total of 24-36 patients will be accrued over 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GENZ-2000-P-0003801 | None | None | None |
| GENZ-ADVMEL-001-99 | None | None | None |
| DFCI-00069 | None | None | None |