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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.

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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Biological: GMCI Drug: Chemotherapy Radiation: Radiation Procedure: Surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma
Study Start Date : October 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Arm
GMCI + chemoadiation + surgery
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

Active Comparator: Control Arm
Chemoradiation + surgery
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




Primary Outcome Measures :
  1. Resection rate [ Time Frame: 4 months ]
    The percentage of patients receiving an R0 resection will be compared between the two arms.

  2. Safety graded by CTC ver4.0 [ Time Frame: 6 months ]
    Frequency of adverse events will be compared between the two arms


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    The percentage of patients alive at 2 years will be compared between the two arms.

  2. Progression-free survival [ Time Frame: 2 years ]
    The PFS curves will be estimated using the Kaplan-Meier method.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446093


Locations
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United States, Florida
Lee Health/Regional Cancer Center Recruiting
Fort Myers, Florida, United States, 33905
Contact: Alina A Ward    239-343-9547    alina.ward@LeeHealth.org   
Contact: Mark Bloomston, MD    (239) 333-0995    mark.bloomston@21co.com   
Principal Investigator: Mark Bloomston, M.D         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Hamida Umar    614-685-6406    Hamida.Umar@osumc.edu   
Contact: Mary Dillhoff, MD    614-293-4583    Mary.Dillhoff@osumc.edu   
Principal Investigator: Mary Dilhoff, MD         
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Mexico, 14080
Contact: Luis Uscanga, M.D    +52 (55)54870900 ext 4401    luis.uscangad@gmail.com   
Sponsors and Collaborators
Advantagene, Inc.
Ohio State University
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Responsible Party: Advantagene, Inc.
ClinicalTrials.gov Identifier: NCT02446093    
Other Study ID Numbers: PaTK02
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: June 2019
Keywords provided by Advantagene, Inc.:
pancreas cancer
immunotherapy
GMCI
AdV-tk
aglatimagene besadenovec
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Valacyclovir
Antiviral Agents
Anti-Infective Agents