Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128583
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
2005-08-08
Brief Title:
Vaccine Therapy in Treating Patients With Malignant Melanoma
Sponsor:
CancerVax Corporation
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent Canvaxin
Status:
UNKNOWN
Status Verified Date:
2005-09
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 tumor cells may help the body build an effective immune response to kill tumor cells
PURPOSE This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma
PURPOSE This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma
Detailed Description:
OBJECTIVES
Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine Canvaxin
OUTLINE This is an open-label multicenter study
Patients receive polyvalent melanoma vaccine Canvaxin subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks 5 doses and then every 4 weeks for up to approximately 1 year of total treatment total of 15 doses Patients with no evidence of response at week 24 receive no further treatment Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine Canvaxin
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
Determine the response in patients with in-transit cutaneous malignant melanoma treated with active immunotherapy comprising polyvalent melanoma vaccine Canvaxin
OUTLINE This is an open-label multicenter study
Patients receive polyvalent melanoma vaccine Canvaxin subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks 5 doses and then every 4 weeks for up to approximately 1 year of total treatment total of 15 doses Patients with no evidence of response at week 24 receive no further treatment Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine Canvaxin
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study
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 |
|---|---|---|---|
| CV-MMAIT-5-001 | None | None | None |