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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

This study is currently recruiting participants.
Verified March 2013 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01595321
First received: April 27, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Pancreatic Cancer
 Drug: Cyclophosphamide
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
Radiation: Stereotactic Body Radiation (SBRT)
Drug: FOLFIRINOX

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of toxicity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    To determine the safety profile of the whole cell vaccine (GVAX) administered along with cyclophosphamide; fractionated SBRT, and FOLFIRINOX.


Secondary Outcome Measures:
  • Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 18
Study Start Date: August 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT and FOLFIRINOX
The first three patients will receive SBRT and FOLFIRINOX only.
 Radiation: Stereotactic Body Radiation (SBRT)
SBRT (6.6 Gy) will be administered over 5 days starting between 7-14 days after the first vaccine dose (Arm 2) or within 12 weeks of surgery (Arm 1 and 2).
Drug: FOLFIRINOX
FOLFIRINOX will be administered over 6 cycles starting less than 1 week after SBRT (Arms 1 and 2) and less than 28 days after the first vaccine (Arm 2).
Other Names:
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • Fluorouracil
Experimental: Cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX
The last 15 patients will receive cyclophosphamide, Vaccine, SBRT, and FOLFIRINOX.
 Drug: Cyclophosphamide
Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0) prior to (1 dose) and after (4 doses) SBRT and FOLFIRINOX for a total of 5 doses.
Other Name: Cytoxan
Biological: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
Vaccine will be administered one day after cyclophosphamide (day 1) prior to (1 dose) and after (4 doses) SBRT and FOLFIRINOX for a total of 5 doses.
Other Name: Pancreatic cancer vaccine
Radiation: Stereotactic Body Radiation (SBRT)
SBRT (6.6 Gy) will be administered over 5 days starting between 7-14 days after the first vaccine dose (Arm 2) or within 12 weeks of surgery (Arm 1 and 2).
Drug: FOLFIRINOX
FOLFIRINOX will be administered over 6 cycles starting less than 1 week after SBRT (Arms 1 and 2) and less than 28 days after the first vaccine (Arm 2).
Other Names:
  • Oxaliplatin
  • Irinotecan
  • Leucovorin
  • Fluorouracil

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. ECOG Performance Status of 0 to 1
  5. Adequate organ function as defined by study-specified laboratory tests
  6. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  7. Signed informed consent form
  8. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595321

Contacts
Contact: Beth Onners, R.N. 410-502-2800 onnerbe@jhmi.edu
Contact: Joseph Herman, M.D. 410-502-3823 jherma15@jhmi.edu

Locations
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Beth Onners, R.N.     410-502-2800     onnerbe@jhmi.edu    
Contact: Joseph Herman, M.D.     410-502-3823     jherma15@jhmi.edu    
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Joseph Herman, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01595321     History of Changes
Other Study ID Numbers: J1179, NA_00050233
Study First Received: April 27, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Adjuvant therapy
Immunotherapy
Cytoxan
Cyclophosphamide
 Pancreatic Vaccine
Stereotactic radiation therapy
SBRT
FOLFIRINOX

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cyclophosphamide
 Fluorouracil
Pancrelipase
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on June 18, 2013