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Report for Clinical Trial NCT00837135

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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. 1. GI-4000 Vaccination: 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. 2. 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.

NCT00837135 Pancreatic Cancer
MeSH:Pancreatic Neoplasms
HPO:Neoplasm of the pancreas

4 Interventions

Name: Screening

Description: A. SCREENING Consent Disease Evaluation (CT Scan/MRI; EGC/EUS; Laparoscopy) Physical Exam, History, Blood Tests Skin Test (for allergy to saccaromyces cerevisiae) yeast. Collection of Blood for research B. CHEMOTHERAPY AND RADIATION (as determined by Doctor) C. ENROLLMENT INTO ACTIVE PART OF STUDY Consent Chemotherapy GI-4000 Vaccine #1 + Prevnar + Activated T Cells GI-4000 Vaccine #2 Disease Evaluation (CT Scan/MRI). If disease has spread, subject is taken off study. If disease is stable, subject go on to ARM A or ARM B.
Type: Other
Group Labels: 1

All Subjects

Name: GI-4000 Vaccine

Description: Chemotherapy and Radiation GI-4000 Vaccine #3 GI-4000 Vaccine #4
Type: Biological
Group Labels: 1

ARM A

Name: GI-4000 Vaccine + Activated T Cells

Description: Apheresis #2 Chemoradiation Activated T Cells + GI-4000 Vaccine #3 GI-4000 Vaccine #4
Type: Biological
Group Labels: 1

ARM B

Name: Surgical Evaluation after Vaccine #4

Description: 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.
Type: Biological
Group Labels: 1

After GI-4000 Vaccine #4


Primary Outcomes

Measure: 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: 1 year

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 5 SNPs

SNPs


1 G12C

1. Histologically-confirmed pancreatic adenocarcinoma that expresses one of the GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R) 2. Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the pancreas and its regional lymph nodes). --- G12V --- --- G12C ---


2 G12D

1. Histologically-confirmed pancreatic adenocarcinoma that expresses one of the GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R) 2. Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the pancreas and its regional lymph nodes). --- G12V --- --- G12C --- --- G12D ---


3 G12V

1. Histologically-confirmed pancreatic adenocarcinoma that expresses one of the GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R) 2. Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the pancreas and its regional lymph nodes). --- G12V ---


4 Q61L

1. Histologically-confirmed pancreatic adenocarcinoma that expresses one of the GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R) 2. Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the pancreas and its regional lymph nodes). --- G12V --- --- G12C --- --- G12D --- --- Q61L ---


5 Q61R

1. Histologically-confirmed pancreatic adenocarcinoma that expresses one of the GI-4000-related k-ras oncoproteins (G12V, G12C, G12D, Q61L, or Q61R) 2. Locally advanced disease, (stages I-III, i.e no evidence of metastasis outside the pancreas and its regional lymph nodes). --- G12V --- --- G12C --- --- G12D --- --- Q61L --- --- Q61R ---



HPO Nodes


HPO: