Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409188
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2006-12-07
Brief Title:
Cancer Vaccine Study for Unresectable Stage III Non-small Cell Lung Cancer START
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
A Multi-center Phase III Randomized Double-blind Placebo-controlled Study of the Cancer Vaccine Stimuvax L-BLP25 or BLP25 Liposome Vaccine in Non-small Cell Lung Cancer NSCLC Subjects With Unresectable Stage III Disease
Status:
COMPLETED
Status Verified Date:
2015-10
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:
START
Brief Summary:
The purpose of this study is to determine whether the cancer vaccine tecemotide L-BLP25 in addition to best supportive care is effective in prolonging the lives of subjects with unresectable stage III non-small cell lung cancer compared to best supportive care alone
A local ancillary sub study in European centers will evaluate the immune response in peripheral blood after tecemotide L-BLP25 or placebo vaccination
A local ancillary sub study in European centers will evaluate the immune response in peripheral blood after tecemotide L-BLP25 or placebo vaccination
Detailed Description:
Ancillary Trial An exploratory investigation of immune response in peripheral blood after tecemotide L-BLP25 or placebo vaccination
The ancillary study is a sub-study within START This is an exploratory investigation of the immune response in peripheral blood after tecemotide L-BLP25 or placebo vaccination The main objective is to evaluate whether administration of single-shot low-dose cyclophosphamide followed by tecemotide L-BLP25 vaccinations induces specific immune response in peripheral blood to BLP25 the mucinous glycoprotein 1 MUC1 antigen as well as a modulation of cellular and soluble components of the immune response in subjects with unresectable stage III NSCLC
Twenty-five of the European START sites will participate in the ancillary study
Sample size up to 60 to 80 subjects
All inclusion criteria specified in the START clinical trial protocol except for hemoglobin 100 gramLiter gL
All exclusion criteria are the same as specified in the START clinical trial protocol
Schedule of events Blood samples will be taken at baseline visit week 4 8 13 and 25 80 milliliter mL whole blood each
The ancillary study is a sub-study within START This is an exploratory investigation of the immune response in peripheral blood after tecemotide L-BLP25 or placebo vaccination The main objective is to evaluate whether administration of single-shot low-dose cyclophosphamide followed by tecemotide L-BLP25 vaccinations induces specific immune response in peripheral blood to BLP25 the mucinous glycoprotein 1 MUC1 antigen as well as a modulation of cellular and soluble components of the immune response in subjects with unresectable stage III NSCLC
Twenty-five of the European START sites will participate in the ancillary study
Sample size up to 60 to 80 subjects
All inclusion criteria specified in the START clinical trial protocol except for hemoglobin 100 gramLiter gL
All exclusion criteria are the same as specified in the START clinical trial protocol
Schedule of events Blood samples will be taken at baseline visit week 4 8 13 and 25 80 milliliter mL whole blood each
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