Phase I - Escalating Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Locally Advanced Adenocarcinoma of the Pancreas, and a Single Dose Study of siG12D LODER (Local Drug EluteR) in Patients With Operable Adenocarcinoma of the Pancreas
Inclusion Criteria:
Phase 0:
Provide written informed consent and be between the ages of 18 and up, inclusive.
- Patient that is diagnosed as respectable locally pancreatic tumor
- Have a target tumor accessible for intratumoral administration by EUS (Endoscopic
Ultrasound) guidance as determined by the physician performing the EUS guided LODER
insertion.
- Have a Karnofsky performance status of ≥ 70%.
- Have a life expectancy of >= 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, , PT, - INR < 1.5 absolute neutrophil count (ANC)
> 1,000 x 103 cells/mL, platelets ≥ 75,000/mL, and hemoglobin >= 10 mg/dL.
- Have screening procedures completed within 2 weeks of starting treatment.
- No other malignancy present that would interfere with the current intervention.
- Have measurable disease.
Phase I
- Provide written informed consent and be between the ages of 18 and up.
- Have an unresectable, locally advanced diagnosed or highly suspected adenocarcinoma
of the pancreas. Or patients with a tumor and are not planed to undergo surgery due
to a high surgical risk (e.g. coagulopathy or severe congestive heart failure).
- Allocated to receive standard of care chemo as first line treatment.
- Have a target tumor 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 of ≥ 70%.
- Have a life expectancy of >= 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, PT - INR < 1.5, absolute neutrophil count (ANC) >
1,000 x 103 cells/mL, platelets ≥ 75,000/mL, and hemoglobin >= 10 mg/dL.
- Have screening procedures completed within 4 weeks of starting treatment.
- No other malignancy present that would interfere with the current intervention.
- Have measurable disease.
Exclusion Criteria:
Phase 0:
- Have distant metastasis spread (such as liver or lung, or lymph nodes metastases),
peritoneal spread or malignant sites.
- 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 bleeding coagulopathy.
- Have participated in any therapeutic research study within the last 4 weeks.
Phase I:
- Have distant metastatic spread (such as liver, lung, or lymph nodes metastases),
peritoneal spread or malignant sites.
- 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 bleeding coagulopathy.
- Have participated in any therapeutic research study within the last 4 weeks.