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GI-4000 With Adoptive Transfer in Pancreatic Cancer

NCT00837135 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-08-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Screening

A. SCREENING 1. Consent 2. Disease Evaluation (CT Scan/MRI; EGC/EUS; Laparoscopy) 3. Physical Exam, History, Blood Tests 4. Skin Test (for allergy to saccaromyces cerevisiae) yeast. 5. Collection of Blood for research B. CHEMOTHERAPY AND RADIATION (as determined by Doctor) C. ENROLLMENT INTO ACTIVE PART OF STUDY 1. Consent 2. Chemotherapy 3. GI-4000 Vaccine #1 + Prevnar + Activated T Cells 4. GI-4000 Vaccine #2 5. 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.

BIOLOGICAL

GI-4000 Vaccine

1. Chemotherapy and Radiation 2. GI-4000 Vaccine #3 3. GI-4000 Vaccine #4

BIOLOGICAL

GI-4000 Vaccine + Activated T Cells

1. Apheresis #2 2. Chemoradiation 3. Activated T Cells + GI-4000 Vaccine #3 4. GI-4000 Vaccine #4

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.

Sponsors & Collaborators

Principal Investigators

  • Peter J. O'Dwyer, MD · University of Pennsylvania

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-10-31
Completion
2009-10-31

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00837135 on ClinicalTrials.gov