Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037713
Status:
COMPLETED
Last Update Posted:
2010-04-08
First Post:
2002-05-20
Brief Title:
Survival in a Randomized Phase III Trial in Patients With Limited Disease LD Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
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:
2010-04
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:
None
Brief Summary:
This trial is designed to test the impact of adjuvant BEC2 25 mgBCG vaccination on survival in patients with LD Small Cell Lung Cancer SCLC Patients will be stratified by institution KPS 60 - 70 vs 80 - 100 and response to first line combined modality therapy CR vs PR that consisted of at least a 2 drug regimen 4 - 6 cycles and a chest radiotherapy regimen Patients will be randomized to one of two treatment arms standard arm Observational cohort or best supportive care or the treatment arm 5 intradermal vaccinations of BEC2 25 mg BCG given on day 1 of weeks 0 2 4 6 and 10
Detailed Description:
None
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