Pancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer, Pancreatic Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 76 |
Updated: | 10/25/2018 |
Start Date: | August 2012 |
End Date: | June 2020 |
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
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.
modulating doses of cyclophosphamide followed by SBRT and FOLFIRINOX chemotherapy in
pancreatic cancer patients after surgery.
Inclusion Criteria (abbreviated):
1. Documented cancer of the pancreas (head, neck, and/or uncinate process), that has been
completely resected
2. No prior Chemotherapy, radiation therapy or biologic therapy for pancreatic cancer
3. Must be within 10 weeks from surgical resection of cancer
4. Titanium clips (minimum 1) must be placed at the time of surgery to aid in SBRT
treatment planning
5. ECOG Performance Status of 0 to 1
6. Adequate organ function as defined by study-specified laboratory tests
7. Must use acceptable form of birth control through the study and for 28 days after
final dose of study drug
8. Signed informed consent form
9. Willing and able to comply with study procedures
Exclusion criteria (abbreviated):
1. Currently have or have history of certain study-specified heart, liver, kidney, lung,
neurological, immune or other medical conditions
2. Presence of metastatic disease
3. 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
4. Systemically active steroids
5. Chemotherapy, radiation therapy or biologic therapy within 28 days prior to receiving
study drug
6. Inability to begin protocol treatment within 70 days (10 weeks) after surgery to
remove cancer
7. History of HIV, hepatitis B or C infection
8. Pregnant or lactating
9. Conditions, including alcohol or drug dependence, or intercurrent illness that would
affect the patient's ability to comply with study visits and procedures
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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