Cancer Vaccines CRS-207 and GVAX Pancreas for Metastatic Pancreatic Adenocarcinoma
Summary
This clinical trial will evaluate the safety, immune response and overall survival of the sequential administration of two cancer vaccines, GVAX Pancreas Vaccine and CRS-207. GVAX vaccines are composed of cancer cells that have been genetically-modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the immune system and that have been irradiated to prevent further cell division. GVAX Pancreas is administered with cyclophosphamide, which has been shown to increase effectiveness of GVAX by inhibiting T regulatory cells. CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent innate and adaptive immunity. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells than on normal cells.
Description
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.
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pancreatic Cancer
Intervention
GVAX Pancreas, Cyclophosphamide and CRS-207, GVAX Pancreas and Cyclophosphamide
Location
H. Lee Moffitt Cancer Center
Tampa
Florida
United States
33612
Status
Active, not recruiting
Source
Aduro BioTech, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01417000
- Information obtained from ClinicalTrials.gov on December 11, 2012
Medical and Biotech [MESH] Definitions
Cyclophosphamide
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Pancreatic Pseudocyst
Cyst-like space not lined by EPITHELIUM and contained within the PANCREAS. Pancreatic pseudocysts account for most of the cystic collections in the pancreas and are often associated with chronic PANCREATITIS.
Pancreas, Exocrine
The major component (about 80%) of the PANCREAS composed of acinar functional units of tubular and spherical cells. The acinar cells synthesize and secrete several digestive enzymes such as TRYPSINOGEN; LIPASE; AMYLASE; and RIBONUCLEASE. Secretion from the exocrine pancreas drains into the pancreatic ductal system and empties into the DUODENUM.
Pancreatic Stellate Cells
Star-shaped, myofibroblast-like cells located in the periacinar, perivascular, and periductal regions of the EXOCRINE PANCREAS. They play a key role in the pathobiology of FIBROSIS; PANCREATITIS; and PANCREATIC CANCER.
Pancreatitis, Acute Necrotizing
A severe form of acute INFLAMMATION of the PANCREAS characterized by one or more areas of NECROSIS in the pancreas with varying degree of involvement of the surrounding tissues or organ systems. Massive pancreatic necrosis may lead to DIABETES MELLITUS, and malabsorption.
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Rare solid tumors of the pancreas can be misinterpreted as primary pancreatic cancer.
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