Status:
COMPLETED
Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer
Lead Sponsor:
Anchiano Therapeutics Israel Ltd.
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intratumorally in patients with unresectable, locally advanced pancrea...
Detailed Description
DTA-H19, is a doubled stranded DNA plasmid that carries the gene for the diphtheria toxn A (DT-A) chain under the regulation of the H19 promoter sequence. This is a Patient-Oriented, Targeted Therapy ...
Eligibility Criteria
Inclusion
- 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 ≤ 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 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, 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.
Exclusion
- Have distant metastatic spread (such as liver or lung metastases), 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00711997
Start Date
August 1 2009
End Date
December 1 2010
Last Update
March 20 2019
Active Locations (4)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201-1595
2
Hadassah University Hospital
Jerusalem, Israel
3
Meir Hospital
Kfar Saba, Israel
4
The Chaim Sheba Medical Center
Tel Litwinsky, Israel