GI-4000 With Adoptive Transfer in Pancreatic Cancer
The purpose of this study is to determine if it is safe to add multiple immunotherapies to standard chemotherapy and radiation for treating pancreatic cancer tumors that cannot be completely removed by surgery.
The first involves a "vaccine," which is an injection (shot) that teaches your immune system to attack foreign invaders. The vaccine we will use is called "GI-4000" - a vaccine composed of yeast that is made to carry the same proteins (called "mutated Ras proteins") found in some pancreatic cancer cells.
- Adoptive T-cell Transfer:
The second type of immunotherapy in this study is called "adoptive T-cell transfer." This involves collecting a specific type of white blood cells from you (called "T-cells")and growing T-cells grown in a lab which may help the research participants' immune systems recover more quickly after chemotherapy, and possibly improved response to other immunotherapies.
We hope that studying these agents together will teach us how to help the immune system fight pancreatic cancer.
|Pancreatic Cancer||Other: Screening Biological: GI-4000 Vaccine Biological: GI-4000 Vaccine + Activated T Cells Biological: Surgical Evaluation after Vaccine #4||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Pilot Study Of Safety And Feasibility Of GI-4000, An Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein Combined With Adoptive Transfer And Chemoradiation in Locally Advanced Pancreatic Cancer|
- To evaluate the feasibility of incorporating GI-4000 vaccine and activated T-cell infusion into a regimen of chemotherapy, radiation, and surgical resection to treat locally advanced pancreatic cancer. [ Time Frame: 1 year ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||October 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: All Subjects
Screening for Eligibility into Trial
B. CHEMOTHERAPY AND RADIATION (as determined by Doctor)
C. ENROLLMENT INTO ACTIVE PART OF STUDY
Experimental: ARM A
Biological: GI-4000 Vaccine
Experimental: ARM B
GI-4000 Vaccine + Activated T Cells
Biological: GI-4000 Vaccine + Activated T Cells
Experimental: After GI-4000 Vaccine #4
GI-4000 Monthly - For those with incomplete removal of tumor GI-4000 Monthly + Chemotherapy - For those with complete removal of tumor
Biological: Surgical Evaluation after Vaccine #4
SURGICAL EVALUATION (to determine disease status) A. For those who have complete removal of tumor. These subjects will continue to receive Chemotherapy AND GI-4000 Vaccination Monthly during Chemotherapy. Disease evaluation every 3-6 months (CT Scan/MR.
B. For those sucjects who cannot have surgery or who have not had complete removal of tumor. These subjects will continue to have GI-4000 Vaccinations Monthly as long as there is no disease progression. Disease evaluation every 3-6 months (CT Scan/MR.
Other Name: GI-4000 Vaccine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837135
|Principal Investigator:||Peter J. O'Dwyer, MD||University of Pennsylvania|