A Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine Alone or Followed by CRS-207 in Adults With Metastatic Pancreatic Adenocarcinoma
This is a Phase 2, randomized, multicenter, open-label study of cyclophosphamide and GVAX
pancreas vaccine followed by CRS-207 in adults with metastatic pancreatic adenocarcinoma who
have received or refused at least one prior chemotherapy treatment.
Eligible subjects will be randomized in a 2:1 ratio to receive either two doses of
cyclophosphamide and GVAX pancreas vaccine and up to 4 doses of CRS-207 at 1 × 10e9 CFU
(Treatment Arm A) or up to six doses of cyclophosphamide and GVAX pancreas vaccine
(Treatment Arm B). Study assessments include blood draws for safety and immune response
monitoring and CT scans for tumor response evaluations.
After completion of treatment, subjects will continue to be followed by phone and optional
clinic visits for the duration of the study. At the investigator's discretion, subjects may
receive additional cycles of the assigned treatment regimen if they are clinically stable
and meet dosing eligibility. At the conclusion of the study, all remaining subjects will be
offered enrollment in a long-term follow-up study.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare overall survival in subjects receiving test treatments
Patients will be followed at regular intervals to assess survival
Up to five years
No
Dung T Le, MD
Principal Investigator
Johns Hopkins University
United States: Food and Drug Administration
ADU-CL-01
NCT01417000
September 2011
October 2014
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Duke University Medical Center | Durham, North Carolina 27710 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Providence Portland Medical Center | Portland, Oregon 97213-3635 |
National Cancer Institute | Bethesda, Maryland 20892-1922 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital | Baltimore, Maryland 21231 |
NYU Langone Medical Center | New York, New York 10016 |
Herbert Irving Comprehensive Cancer Center of Columbia University | New York, New York 10032 |