Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089726
Status:
COMPLETED
Last Update Posted:
2007-12-24
First Post:
2004-08-11
Brief Title:
A Cancer Vaccine CG8123 Given With and Without Cyclophosphamide for Advanced Stage Non-Small Cell Lung Cancer NSCLC
Sponsor:
Cell Genesys
Organization:
Cell Genesys
Study Overview
Official Title:
A Phase II Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine CG8123 With and Without Low-Dose Cyclophosphamide in Advanced Stage Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this research study is to determine if a vaccine made from a patients lung cancer tumor cells will be effective in making the cancer shrink or disappear The vaccine will be given by itself to some patients while other patients will get the vaccine with cyclophosphamide a type of chemotherapy Studies in animals and other cancer vaccine trials suggest that cyclophosphamide may make tumor vaccines more potent This study will try to determine if vaccine given with or without this chemotherapy is effective in destroying lung cancer cells Additionally the study will collect information on vaccine safety both with and without chemotherapy and whether the vaccine improves lung cancer-related symptoms eg shortness of breath
Tumors from surgical resection will be processed and made into a vaccine Prior to treatment patients will be randomized equally to one of two treatment groups Cohort A and Cohort B Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first third and fifth vaccine treatments Patients will receive intradermal beneath the skin vaccine injections every two weeks for up to eight weeks for a total of up to five vaccine treatments The duration of this study including active follow up is approximately two years After this patients will be followed-up yearly for a total of 15 years
Tumors from surgical resection will be processed and made into a vaccine Prior to treatment patients will be randomized equally to one of two treatment groups Cohort A and Cohort B Patients in Cohort A will be treated with CG8123 vaccine only and patients in Cohort B will be treated with CG8123 vaccine plus a single dose of cyclophosphamide administered one day prior to the first third and fifth vaccine treatments Patients will receive intradermal beneath the skin vaccine injections every two weeks for up to eight weeks for a total of up to five vaccine treatments The duration of this study including active follow up is approximately two years After this patients will be followed-up yearly for a total of 15 years
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