The purpose of this study is to estimate safety of a whole cell vaccine with immune
modulating doses of cyclophosphamide followed by SBRT and FOLFIRINOX chemotherapy in
pancreatic cancer patients after surgery.
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
Radiation: Stereotactic Body Radiation (SBRT)
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01595321
Ages eligible for Study
18 Years to 76 Years
Genders eligible for Study
Accepts Healthy Volunteers
Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been completely resected
No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer
Must be within 10 weeks from surgical resection of cancer
Titanium clips (minimum 1) must be placed at the time of surgery to aid in SBRT treatment planning
ECOG Performance Status of 0 to 1
Adequate organ function as defined by study-specified laboratory tests
Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
Signed informed consent form
Willing and able to comply with study procedures
Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
Presence of metastatic disease
Clinical metabolic or laboratory abnormalities defined as Grade 3 or 4 of the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
Systemically active steroids
Chemotherapy, radiation therapy or biologic therapy within 28 days prior to receiving study drug
Inability to begin protocol treatment within 70 days (10 weeks) after surgery to remove cancer
History of HIV, hepatitis B or C infection
Pregnant or lactating
Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
All locations for NCT01595321
United States (1)
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
View full eligibility
Tris trial is registered with FDA with number: NCT01595321. The sponsor of the trial is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and it is looking for 19 volunteers for the current phase.
Official trial title: Pilot Study Evaluating An Allogeneic GM-CSF-Transduced Pancreatic Tumor Cell Vaccine (GVAX) and Low Dose Cyclophosphamide Integrated With Fractionated Stereotactic Body Radiation Therapy (SBRT) and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
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