Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455572
Status:
TERMINATED
Last Update Posted:
2017-05-15
First Post:
2007-04-02
Brief Title:
Cancer Immunotherapy GSK1572932A as Adjuvant Therapy for Patients With Tumor-antigen-positive Non-Small Cell Lung Cancer
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to find out how successfully non-small-cell lung cancer patients are able to give an immune response to injections of the immunotherapeutic product GSK1572932A and to find out more about the safety of this treatment A course of eight injections will be administered over 21 weeks including screening for suitability and all tests the duration of the study for a patient will be 30-35 weeks During this period various tests will be performed including physical examinations and blood tests The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
This is an open four-arm parallel-group study to be conducted at approximately 20 centers in Europe and Canada All patients will receive the same immunotherapeutic treatment with GSK1572932A but they will be recruited into four cohorts according to the details of their disease Cohort 1 Patients with resected stage IB II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine These patients will receive chemo-and immunotherapy in parallel Cohort 2 Patients with resected stage IB II or IIIA tumors who are due for standard chemotherapy with cisplatin and vinorelbine These patients will first receive chemotherapy and then immunotherapy
Cohort 3 Patients with resected stage IB II or IIIA tumors who are not due for chemotherapy These patients will receive immunotherapy only Cohort 4 Patients with unresectable stage III tumors following standard chemotherapy andor radiotherapy These patients will receive immunotherapy only Immunotherapeutic treatment will comprise eight doses of GSK1572932A Doses will be administered at three-week intervals in Cohort 1 this may be adapted to fit in with the patients chemotherapy During the study adjuvant radiotherapy is allowed in Cohorts 1 2 and 3 for patients in stage III only and is prohibited in Cohort 4 Chemotherapy during the study is allowed in Cohort 1 only as described above and is prohibited in Cohorts 2-4 The total maximum duration of the study for a patient will be 30-35 weeks
Cohort 3 Patients with resected stage IB II or IIIA tumors who are not due for chemotherapy These patients will receive immunotherapy only Cohort 4 Patients with unresectable stage III tumors following standard chemotherapy andor radiotherapy These patients will receive immunotherapy only Immunotherapeutic treatment will comprise eight doses of GSK1572932A Doses will be administered at three-week intervals in Cohort 1 this may be adapted to fit in with the patients chemotherapy During the study adjuvant radiotherapy is allowed in Cohorts 1 2 and 3 for patients in stage III only and is prohibited in Cohort 4 Chemotherapy during the study is allowed in Cohort 1 only as described above and is prohibited in Cohorts 2-4 The total maximum duration of the study for a patient will be 30-35 weeks
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