Pancreatic Cancer - Phase I/IIa Clinical Trial of BC-819 - Inclusion/Exclusion Criteria

Inclusion Criteria

Potential patients will include those with a histologic or cytologic diagnosis of pancreatic adenocarcinoma that is not surgically resectable. Patients must also have a marker tumor that is less than 6 cm in diameter that is accessible for intratumoral administration by PTA or EUS and that is positive for H19 expression.

Patients must:

• Provide written informed consent and be between the ages of 18 and 79, inclusive.
• Have unresectable, locally advanced adenocarcinoma of the pancreas proven by biopsy or cytology (defined as direct extension to the superior mesenteric artery and/or celiac axis with loss of a clear plane between tumor and these arterial structures, or loss of patent superior mesenteric-portal vein confluence). Patients who have been surgically explored and deemed unresectable on that basis are eligible, provided other entry criteria are met. Patients having potentially resectable regional lymph node involvement may be included.
• Have a target tumor less than 6 cm in diameter that is accessible for intratumoral administration by PTA or EUS guidance as determined by the radiologist/ gastroenterologist performing the PTA/EUS injection.
• Have a Karnofsky performance status greater than 70%.
• Have a life expectancy greater than 3 months.
• If female and of child-bearing potential, have a negative serum pregnancy test during screening.
• Agree to use of a barrier method of contraception if sexually active (both men and women) from the time of administration of the first treatment and for at least 8 weeks after treatment.
• Have serum creatinine < 2.0 mg/dL, AST and ALT £ 2.5 x ULN, PT, PPT, and PT/INR within normal limits, absolute neutrophil count (ANC) > 1,500 x 10³ cells/mL, platelets ≥ 100,000/mL, and hemoglobin ≥ 10 mg/dL.
• Have a biopsy specimen that is positive for H19 expression (grade 2 or greater staining determined by a pathologist).
• Have screening procedures completed within 4 weeks of starting treatment.
• No other malignancy present that would interfere with the current intervention.
• Commit to refrain from any concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol; therefore any standard treatment should be postponed while on study.
• Have measurable disease.

Note: Previous surgery is not a contraindication. Patients who have had previous surgery or who have received prior chemotherapy for pancreatic cancer are eligible as long as they still have locally advanced pancreatic cancer before enrollment.  Patients who have received irradiation for pancreatic cancer are not eligible as radiation can cause scarring that could interfere with injections and resection.

Exclusion Criteria

Patients must not:

• Have distant metastatic spread (such as liver or lungmetastases), peritoneal spread or malignant ascites.
• Have prior radiation therapy for pancreatic cancer or radiation to the area of the target tumor field.
• Endocrine tumors or lymphoma of the pancreas.
• Have clinically significant pancreatitis within 12 weeks of treatment.
• If female, be breast feeding.
• Have a medical condition contraindicated for both percutaneous- and endoscopic- guided delivery or any intercurrent medical illness or other medical condition that would in the judgment of the investigator compromise patient safety or the objectives of the study.
• Have a history of coagulopathy.
• Have participated in any therapeutic research study within the last 4 weeks.

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