Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments cyclophosphamide, panc 10.05 pcdna-1/gm-neo and panc 6.03 pcdna-1/gm-neo vaccine, stereotactic body radiation (sbrt), folfirinox
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date August 2012
End date July 2017
Trial size 19 participants
Trial identifier NCT01595321, J1179, NA_00050233

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The first 6 patients will receive SBRT and FOLFIRINOX only.
stereotactic body radiation (sbrt)
SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first vaccine dose (Arm 2) or within 6-10 weeks of surgery (Arm 1).
folfirinox Oxaliplatin
FOLFIRINOX will be administered over 6 cycles starting at least 14 days after SBRT (Arms 1 and 2) and at least 28 days after the first vaccine (Arm 2).
(Experimental)
The last 12 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.
cyclophosphamide Cytoxan
Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional Cy-vaccine boosts may be given every 6 months thereafter until disease recurrence.
panc 10.05 pcdna-1/gm-neo and panc 6.03 pcdna-1/gm-neo vaccine Pancreatic cancer vaccine
Vaccine will be administered one day after cyclophosphamide (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional Cy-vaccine boosts may be given every 6 months thereafter until disease recurrence.
stereotactic body radiation (sbrt)
SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first vaccine dose (Arm 2) or within 6-10 weeks of surgery (Arm 1).
folfirinox Oxaliplatin
FOLFIRINOX will be administered over 6 cycles starting at least 14 days after SBRT (Arms 1 and 2) and at least 28 days after the first vaccine (Arm 2).

Primary Outcomes

Measure
Number of participants with adverse events as a measure of toxicity
time frame: 4 years

Secondary Outcomes

Measure
Survival
time frame: 4 years
Time to disease progression using immune correlates
time frame: 4 years

Eligibility Criteria

Male or female participants from 18 years up to 76 years old.

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

Additional Information

Official 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
Principal investigator Daniel Laheru, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.