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
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: The Skip Viragh Foundation
• Treatments: Cyclophosphamide; Fluorouracil; Folfirinox; Irinotecan; Leucovorin; Oxaliplatin; Pancrelipase; Vaccines

Criteria

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