Status:
COMPLETED
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines made from gene-modified tumor cells may help the body build an effective immune response to kill pancreatic cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work...
Detailed Description
OBJECTIVES: Primary * To evaluate the safety and feasibility of a GVAX pancreatic cancer vaccine (GM-CSF gene-transfected allogeneic pancreatic cancer vaccine) when administered alone or in combinat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas
- Stage I or II disease
- Surgically resectable disease (R0 or R1) by spiral CT scan
- No distant metastases
- A clear fat plane is present around the celiac and superior mesenteric arteries
- Patent superior mesenteric and portal veins
- Candidate for a pancreaticoduodenectomy
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine ≤ 2 mg/dL
- AST and ALT ≤ 2 times upper limit of normal (ULN)
- Amylase ≤ 2 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Hyperbilirubinemia secondary to tumor-associated extrahepatic biliary obstruction allowed
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 4 weeks after the completion of study treatment
- No history of autoimmune disease, including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
- No uncontrolled medical problems
- No active infections
- No other cancer within the past 5 years except for superficial bladder cancer, nonmelanoma skin cancer, or low-grade prostate cancer not requiring therapy
- PRIOR CONCURRENT THERAPY:
- More than 28 days since prior anticancer therapy
- No prior cancer immunotherapy, including the same pancreatic cancer vaccine used in this study
- More than 28 days since prior systemic steroid therapy or immunosuppressive therapy
- No systemic steroid therapy or immunosuppressive therapy during and within 28 days after vaccine administration
- No other concurrent immunotherapy, chemotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy for the treatment of pancreatic cancer
Exclusion
Key Trial Info
Start Date :
July 2 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00727441
Start Date
July 2 2008
End Date
February 1 2019
Last Update
February 25 2020
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410