Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005052
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2000-04-06
Brief Title:
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Adjuvant Ganglioside GM2-KLHQS-21 Vaccination Post-Operative Adjuvant Ganglioside GM2-KLHQS-21 BMS-248479 Vaccination Treatment After Resection of Primary Cutaneous Melanoma Thicker Than 15mm AJCCUICC Stage II T3-T4N0M0 a 2-Arm Multicenter Randomized Phase III Trial vs Observation
Status:
UNKNOWN
Status Verified Date:
2006-01
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 It is not yet known whether vaccine therapy is more effective than observation alone for melanoma
PURPOSE This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma
PURPOSE This randomized phase III trial is studying vaccine therapy to see how well it works compared to observation alone in treating patients with primary stage II melanoma
Detailed Description:
OBJECTIVES
Compare the effect of immunization with GM2-KLH and QS21 to observation on the disease-free survival of patients with primary cutaneous stage II melanoma after adequate surgery
Determine overall survival and toxicity in the two treatment arms
OUTLINE This is a randomized open-label parallel multicenter study Patients are stratified according to participating center tumor thickness greater than 15 to 30 mm vs greater than 30 to 40 mm vs greater than 40 mm gender ulceration yes vs no and presence of additional staging procedures of regional lymph nodes yes vs no Patients are randomized to one of two arms
Arm I Patients are vaccinated with GM2-KLH and QS21 subcutaneously on day 1 of weeks 1-4 12 24 36 48 60 72 84 96 120 and 144 for a total of 14 vaccinations
Arm II Patients undergo observation Patients are followed every 6 months for 7 years
PROJECTED ACCRUAL A total of 1300 patients 650 per arm will be accrued for this study within 36 months
Compare the effect of immunization with GM2-KLH and QS21 to observation on the disease-free survival of patients with primary cutaneous stage II melanoma after adequate surgery
Determine overall survival and toxicity in the two treatment arms
OUTLINE This is a randomized open-label parallel multicenter study Patients are stratified according to participating center tumor thickness greater than 15 to 30 mm vs greater than 30 to 40 mm vs greater than 40 mm gender ulceration yes vs no and presence of additional staging procedures of regional lymph nodes yes vs no Patients are randomized to one of two arms
Arm I Patients are vaccinated with GM2-KLH and QS21 subcutaneously on day 1 of weeks 1-4 12 24 36 48 60 72 84 96 120 and 144 for a total of 14 vaccinations
Arm II Patients undergo observation Patients are followed every 6 months for 7 years
PROJECTED ACCRUAL A total of 1300 patients 650 per arm will be accrued for this study within 36 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 |
|---|---|---|---|
| BMS-CA152-003 | None | None | None |
| EORTC-18961 | None | None | None |