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Sponsored by: |
BioCancell Therapeutics Ltd |
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Information provided by: | BioCancell Therapeutics Ltd |
ClinicalTrials.gov Identifier: | NCT00711997 |
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 pancreatic cancer. Primary Objective: The primary objective is to determine the maximum tolerated dose (MTD) of intratumoral DTA-H19 and identify any dose limiting toxicities (DLTs). Secondary objectives include determining the adverse events (AEs) profile, effects on clinical laboratory analytes, vital signs, PK, tumor response, and possible tumor resectability after 4 intratumoral administrations of DTA-H19.
Condition | Intervention | Phase |
---|---|---|
Pancreatic Neoplasms |
Biological: DTA-H19 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 1/2a, Dose-Escalation, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Intratumoral Administration of DTA-H19 in Patients With Unresectable Pancreatic Cancer |
Estimated Enrollment: | 12 |
Study Start Date: | March 2009 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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 as DT-A chain expression is triggered by the presence of H19 transcription factors that are upregulated in tumor cells. The selective initiation of toxin expression results in selective tumor cell destruction via inhibition of protein synthesis in the tumor cell, enabling highly targeted cancer treatment.
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patricia Ohana, Ph.D | 972-2-6585457 | pohana@biocancell.com |
Contact: Ifat Liven, Msc | 972-542404165 | ifat.liven@biocancell.com |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201-1595 | |
United States, Virginia | |
Massey Cancer Center, Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298-0037 | |
Israel | |
The Chaim Sheba Medical Center | |
Tel Hashomer, Israel |
Principal Investigator: | Abraham Czerniak, MD | The Chaim Sheba Medical Center |
Principal Investigator: | John D Roberts, M.D. | Massey Cancer Center |
Principal Investigator: | Nader Hanna, MD, FACS, FICS | University of Maryland Medical Center |
Responsible Party: | BioCancell Therapeutics Ltd ( Patricia Ohana Ph.D. ) |
Study ID Numbers: | BC-07-05 |
Study First Received: | July 8, 2008 |
Last Updated: | January 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00711997 History of Changes |
Health Authority: | United States: Food and Drug Administration; Israel: Ministry of Health |
H19 gene, plasmid, diphtheria toxin, pancreatic cancer |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases |
Gastrointestinal Neoplasms Endocrinopathy Diphtheria Endocrine Gland Neoplasms |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Endocrine Gland Neoplasms |