Back to resultsPancreatic Tumor Cell Vaccine (GVAX), Low Dose Cyclophosphamide, Fractionated Stereotactic Body Radiation Therapy (SBRT), and FOLFIRINOX Chemotherapy in Patients With Resected Adenocarcinoma of the Pancreas
Primary Purpose
Pancreatic Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
Stereotactic Body Radiation (SBRT)
FOLFIRINOX
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Adjuvant therapy, Immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, Stereotactic radiation therapy, SBRT, FOLFIRINOX
Eligibility Criteria
Inclusion Criteria (abbreviated):
- 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
Exclusion criteria (abbreviated):
- 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
Sites / Locations
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SBRT and FOLFIRINOX
Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX
Arm Description
The first 6 patients will receive SBRT and FOLFIRINOX only.
The last 12 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.
Outcomes
Primary Outcome Measures
Number of participants with adverse events as a measure of toxicity
To determine the safety profile of the whole cell vaccine (GVAX) administered along with cyclophosphamide; fractionated SBRT, and FOLFIRINOX.
Secondary Outcome Measures
Survival
To estimate the median overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DMFS) using Kaplan-Meier techniques.
Time to disease progression using immune correlates
Correlate progression with the immune response through vaccine-induced changes in the number, function, avidity, size and diversity of the mesothelin-specific T cell repertoire).
Full Information
NCT ID
NCT01595321
First Posted
April 27, 2012
Last Updated
March 6, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
The Skip Viragh Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01595321
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 29, 2012 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
The Skip Viragh Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Adjuvant therapy, Immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, Stereotactic radiation therapy, SBRT, FOLFIRINOX
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBRT and FOLFIRINOX
Arm Type
Experimental
Arm Description
The first 6 patients will receive SBRT and FOLFIRINOX only.
Arm Title
Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX
Arm Type
Experimental
Arm Description
The last 12 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
Other Intervention Name(s)
Pancreatic cancer vaccine
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation (SBRT)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
FOLFIRINOX
Other Intervention Name(s)
Oxaliplatin, Irinotecan, Leucovorin, Fluorouracil
Intervention Description
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 Outcome Measure Information:
Title
Number of participants with adverse events as a measure of toxicity
Description
To determine the safety profile of the whole cell vaccine (GVAX) administered along with cyclophosphamide; fractionated SBRT, and FOLFIRINOX.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Survival
Description
To estimate the median overall survival (OS), disease-free survival (DFS), and distant metastases free survival (DMFS) using Kaplan-Meier techniques.
Time Frame
4 years
Title
Time to disease progression using immune correlates
Description
Correlate progression with the immune response through vaccine-induced changes in the number, function, avidity, size and diversity of the mesothelin-specific T cell repertoire).
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (abbreviated):
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
Exclusion criteria (abbreviated):
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Laheru, M.D.
Organizational Affiliation
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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