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Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma

Trial Status: Active

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.

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

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Hamida Umar
Phone: 614-685-6406

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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Candel Therapeutics, Inc.

  • Primary ID PaTK02
  • Secondary IDs NCI-2015-00859
  • Clinicaltrials.gov ID NCT02446093