Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma (PaTK02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02446093
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : May 11, 2020
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Advantagene, Inc.

Tracking Information
First Submitted Date  ICMJE April 14, 2015
First Posted Date  ICMJE May 18, 2015
Last Update Posted Date May 11, 2020
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Resection rate [ Time Frame: 4 months ]
    The percentage of patients receiving an R0 resection will be compared between the two arms.
  • Safety graded by CTC ver4.0 [ Time Frame: 6 months ]
    Frequency of adverse events will be compared between the two arms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2015)
  • Overall survival [ Time Frame: 2 years ]
    The percentage of patients alive at 2 years will be compared between the two arms.
  • Progression-free survival [ Time Frame: 2 years ]
    The PFS curves will be estimated using the Kaplan-Meier method.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma
Official Title  ICMJE Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma
Brief Summary The purpose of this study is to evaluate Gene Mediated Cytotoxic Immunotherapy (GMCI™) in combination with standard of care chemoradiation and surgery for borderline resectable and unresectable locally advanced pancreatic cancer in patients who have completed induction chemotherapy. GMCI kills tumor cells and creates an immune stimulatory environment in the tumor. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. GMCI has shown synergy with radiation and surgery without added toxicity. The hypothesis is that GMCI added to standard of care chemoradiation and surgery after completion of induction chemotherapy will be safe and will improve the clinical outcome for patients with pancreatic cancer.
Detailed Description

GMCI involves the injection of aglatimagene besadenovec (AdV-tk) into the tumor followed by oral valacyclovir pills to kill tumor cells and stimulate a cancer vaccine effect. The current protocol is designed to deliver multiple courses of GMCI in combination with standard of care chemoradiation and surgery to capitalize on the synergies with the different treatment modalities.

This protocol includes two phases:

  • Phase 1b - completed.
  • The Phase 2 is a randomized study comparing a test group receiving GMCI added to chemoradiation and surgery to a control arm receiving chemoradiation followed by surgery. Participants will be randomized in a 1:1 ratio to GMCI plus standard of care or standard of care alone. Both arms receive standard of care treatment and evaluations.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Adenocarcinoma
Intervention  ICMJE
  • Biological: GMCI
    Intratumoral cytotoxic immunotherapy using an adenoviral vector expressing HSV-tk followed by anti-herpetic prodrug valacyclovir
    Other Name: AdV-tk (aglatimagene besadenovec) + valacyclovir
  • Drug: Chemotherapy
    Standard of care chemotherapy given with radiation
  • Radiation: Radiation
    Other Name: Standard of care radiation given with chemotherapy
  • Procedure: Surgery
    Pancreaticoduodenectomy (Whipple)
    Other Name: Pancreatic cancer resection
Study Arms  ICMJE
  • Experimental: Test Arm
    GMCI + chemoadiation + surgery
    Interventions:
    • Biological: GMCI
    • Drug: Chemotherapy
    • Radiation: Radiation
    • Procedure: Surgery
  • Active Comparator: Control Arm
    Chemoradiation + surgery
    Interventions:
    • Drug: Chemotherapy
    • Radiation: Radiation
    • Procedure: Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2019)
38
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2015)
44
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathological diagnosis of pancreatic adenocarcinoma adequately treated with induction chemotherapy for at least 2 months such that they are a candidate for localized therapy with chemoradiation followed by surgery with or without major vascular resection.
  • Patients must be deemed to be in adequate health to undergo major surgery (pancreaticoduodenectomy)
  • Tumor accessible for injection that is classified as borderline-resectable or locally advanced but considered potentially resectable after central review by surgical investigators (based upon pre-induction chemotherapy imaging). Resection may include major vascular resection with reconstruction as needed.
  • Age 18-76 years
  • Performance status ECOG 0-1
  • SGOT (AST)<3x upper limit of normal
  • Total bilirubin ≤2mg/dl
  • Creatinine<2mg/dl
  • Calculated creatinine clearance >30ml/m
  • WBC>3000/mm3
  • Absolute neutrophil count (ANC)>1500/mm3
  • Platelets>100,000/mm3
  • Hemoglobin > 9 g/dL.
  • Patients must give study specific informed consent prior to enrollment

Exclusion Criteria:

  • Primary hepatic dysfunction including known cirrhosis or active hepatitis. Patients with biliary obstruction must be stented prior to initiating treatment.
  • Evidence of clinically significant pancreatitis as determined by the investigator
  • Evidence of significant ascites as determined by the investigator
  • Patients on systemic corticosteroids (>10 mg prednisone per day or equivalent) or other systemic immunosuppressive drugs
  • Known to be HIV+
  • Pregnant or breast-feeding. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy.
  • Other current malignancy (except squamous or basal cell skin cancers)
  • Other serious co-morbid illness or compromised organ function
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02446093
Other Study ID Numbers  ICMJE PaTK02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Advantagene, Inc.
Study Sponsor  ICMJE Advantagene, Inc.
Collaborators  ICMJE Ohio State University
Investigators  ICMJE Not Provided
PRS Account Advantagene, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP