Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003279
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
1999-11-01
Brief Title:
Vaccination Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
The SILVA Study Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
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:
SILVA
Brief Summary:
RATIONALE Vaccines may help the body build an immune response to kill tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of vaccination with monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who have limited-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of vaccination with monoclonal antibody BEC2 and BCG with that of no further therapy in treating patients who have limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the impact of adjuvant monoclonal antibody BEC2 and BCG on survival of patients with limited stage small cell lung cancer II Determine the safety of this regimen in these patients III Determine progression-free survival and quality of life of these patients treated with this regimen
OUTLINE This is a randomized multicenter study Patients are stratified according to center Karnofsky performance status 60-70 vs 80-100 and response to first-line combined modality treatment complete vs partial Within 3-7 weeks after completion of prior induction chemoradiotherapy responding patients are randomized to 1 of 2 treatment arms Arm I Patients receive best supportive care and are observed until disease progression is documented Arm II Patients receive adjuvant monoclonal antibody BEC2 and BCG intradermally on day 1 of weeks 0 2 4 6 and 10 Treatment consists of 5 vaccinations over a period of 10 to 12 weeks in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline at weeks 6 12 and 24 and then every 6 months thereafter Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study within 4 years
OUTLINE This is a randomized multicenter study Patients are stratified according to center Karnofsky performance status 60-70 vs 80-100 and response to first-line combined modality treatment complete vs partial Within 3-7 weeks after completion of prior induction chemoradiotherapy responding patients are randomized to 1 of 2 treatment arms Arm I Patients receive best supportive care and are observed until disease progression is documented Arm II Patients receive adjuvant monoclonal antibody BEC2 and BCG intradermally on day 1 of weeks 0 2 4 6 and 10 Treatment consists of 5 vaccinations over a period of 10 to 12 weeks in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline at weeks 6 12 and 24 and then every 6 months thereafter Patients are followed every 3 months
PROJECTED ACCRUAL Approximately 500 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| UCLA-9902001 | None | None | None |
| EORTC-08971 | None | None | None |