Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]Number of Participants Reaching Maximal Tolerated Dose (MTD)
- Tumor Response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Tumor response and progression were defined in accordance with RECIST v. 1.0 and assessed by radiological examination 2 weeks after the end of treatment
- Tumor Resectability [ Time Frame: 5 to 6 weeks ] [ Designated as safety issue: No ]The number of subjects in each cohort whose tumor was resectable at the end of the study was to be presented for the ITT and the per-protocol population.
|Study Start Date:||August 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Intratumoral administration of BC-819
Cohort #1: 4 mg DTA-H19 intratumorally 2 times per week for 2 weeks Cohort #2: 8 mg DTA-H19 intratumorally 2 times per week for 2 weeks
Other Name: BC-819
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.
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201-1595|
|Hadassah University Hospital|
|Kfar Saba, Israel|
|The Chaim Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Abraham Czerniak, MD||The Chaim Sheba Medical Center|
|Principal Investigator:||Nader Hanna, MD, FACS||University of Maryland|
|Principal Investigator:||Fred Konikoff, MD||Meir Medical Center|
|Principal Investigator:||Ayala Hubert, MD||Hadassah University Hospital|