Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004025
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Stage III or Stage IV Melanoma
Sponsor:
Genzyme a Sanofi Company
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of the Safety Immunogenicity and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 rIL-2 in Patients With Stage 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 made from a persons white blood cells combined with melanoma antigens may make the body build an immune response to tumor cells Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells Combining vaccine therapy with interleukin-2 may be an effective treatment for stage III or stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed
PURPOSE Phase III trial to study the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have stage III or stage IV melanoma that cannot be surgically removed
Detailed Description:
OBJECTIVES I Evaluate the safety dose-limiting toxicity and maximum tolerated dose of autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma II Evaluate the cellular response and efficacy of these regimens in this patient population
OUTLINE This is a dose-escalation study Patients are sequentially assigned to one of three dose levels Patients receive modified autologous dendritic cells subcutaneously on day 1 with or without interleukin-2 IV on days 4-19 Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of modified dendritic cells with or without interleukin-2 until the maximum tolerated dose MTD for each regimen is reached The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 24-36 patients will be accrued for this study within 1 year
OUTLINE This is a dose-escalation study Patients are sequentially assigned to one of three dose levels Patients receive modified autologous dendritic cells subcutaneously on day 1 with or without interleukin-2 IV on days 4-19 Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of modified dendritic cells with or without interleukin-2 until the maximum tolerated dose MTD for each regimen is reached The MTD is defined as the dose below that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 24-36 patients will be accrued for this study within 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 |
|---|---|---|---|
| DFCI-98258 | None | None | None |
| GENZ-ML98-0501 | None | None | None |