Neoadjuvant GMCI Plus Chemoradiation for Advanced Non-Metastatic Pancreatic Adenocarcinoma

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Advantagene, Inc.; Candel Therapeutics, Inc.
• Collaborator: Ohio State University
• Treatments: Gemcitabine; Valacyclovir

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