Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074295
Status:
TERMINATED
Last Update Posted:
2012-07-24
First Post:
2003-12-10
Brief Title:
S0310 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Bronchoalveolar Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of CG8123 an Autologous Cancer Vaccine GVAX in Patients With Selected Stage IIIB and IV Bronchioloalveolar Carcinoma BAC
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
closed due to lack of availability of vaccine
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from a persons tumor tissue may make the body build an immune response to kill tumor cells
PURPOSE This phase II trial is studying vaccine therapy to see how well it works in treating patients with stage IIIB or stage IV bronchoalveolar lung cancer
PURPOSE This phase II trial is studying vaccine therapy to see how well it works in treating patients with stage IIIB or stage IV bronchoalveolar lung cancer
Detailed Description:
OBJECTIVES
Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine
Determine the response rate confirmed and unconfirmed and complete and partial in patients treated with this vaccine
Determine the frequency and severity of toxic effects of this vaccine in these patients
Determine the functional status of patients treated with this vaccine
Correlate systemic biologic activity ie antigen-specific antitumor and systemic cytokine responses with clinical outcome in patients treated with this vaccine
OUTLINE This is a multicenter study Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma BAC yes vs no and pattern of BAC diffuse vs nodular
After successful vaccine manufacturing from tumor tissue procured patients receive GVAX lung cancer vaccine intradermally ID 6-7 injections per vaccination on weeks 1 3 5 7 and 9 for a total of 5 vaccinations Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at weeks 9 13 and 21
Patients are followed at 4 weeks every 8 weeks for 1 year and then every 12 weeks for 2 years
PROJECTED ACCRUAL A total of 117 patients 67 previously untreated and 50 previously treated will be accrued for this study
Determine the progression-free and overall survival of patients with selected stage IIIB or stage IV bronchoalveolar carcinoma treated with GVAX lung cancer vaccine
Determine the response rate confirmed and unconfirmed and complete and partial in patients treated with this vaccine
Determine the frequency and severity of toxic effects of this vaccine in these patients
Determine the functional status of patients treated with this vaccine
Correlate systemic biologic activity ie antigen-specific antitumor and systemic cytokine responses with clinical outcome in patients treated with this vaccine
OUTLINE This is a multicenter study Patients are stratified according to prior systemic cancer therapy for bronchoalveolar carcinoma BAC yes vs no and pattern of BAC diffuse vs nodular
After successful vaccine manufacturing from tumor tissue procured patients receive GVAX lung cancer vaccine intradermally ID 6-7 injections per vaccination on weeks 1 3 5 7 and 9 for a total of 5 vaccinations Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline and at weeks 9 13 and 21
Patients are followed at 4 weeks every 8 weeks for 1 year and then every 12 weeks for 2 years
PROJECTED ACCRUAL A total of 117 patients 67 previously untreated and 50 previously treated will be accrued for this study
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 |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0310 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |