Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098085
Status:
COMPLETED
Last Update Posted:
2009-03-09
First Post:
2004-12-03
Brief Title:
Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer
Sponsor:
Agenus Inc
Organization:
Agenus Inc
Study Overview
Official Title:
A Phase II Study of the Feasibility to Derive Autologous Vaccine HSPPC-96 From Tumor Tissue for Clinical Administration in Patients With Resectable Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2009-03
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:
Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine HSPPC-96 from the tumor tissue of patients with resectable non-small cell lung cancer
Vaccine production will be attempted on all patients who undergo surgery and meet all inclusionexclusion criteria
Vaccine production will be attempted on all patients who undergo surgery and meet all inclusionexclusion criteria
Detailed Description:
Antigenics is enrolling patients in a Phase II study testing the feasibility to derive an autologous investigational vaccine HSPPC-96 from the tumor tissue of patients with resectable non-small cell lung cancer
All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival
The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer
The secondary goals are to further characterize the safety and efficacy profile to evaluate disease recurrence in patients receiving and to evaluate overall survival in patients receiving HSPPC-96
HSPPC-96 is an investigational immunotherapeutic agent made from an individual patients own tumor which is collected at the time of surgery A portion of the tumor tissue is sent to Antigenics manufacturing facility where it will undergo processing to create a vaccine This vaccine may help the patients immune system attack cancerous cells while leaving healthy cells alone
All patients will undergo surgery to remove the tumor and will be followed for recurrence and overall survival
The primary goal of this trial is to determine if HSPPC-96 can be made from the tumor tissue of patients with resectable non-small cell lung cancer
The secondary goals are to further characterize the safety and efficacy profile to evaluate disease recurrence in patients receiving and to evaluate overall survival in patients receiving HSPPC-96
HSPPC-96 is an investigational immunotherapeutic agent made from an individual patients own tumor which is collected at the time of surgery A portion of the tumor tissue is sent to Antigenics manufacturing facility where it will undergo processing to create a vaccine This vaccine may help the patients immune system attack cancerous cells while leaving healthy cells alone
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