Phase 1/2a DTA-H19 in Patients With Unresectable Pancreatic Cancer

NCT00711997 | Completed Phase 1 Results

• 1 other identifier: BC-07-05
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 4

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 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.

Conditions

Pancreatic Neoplasms

Keywords

H19 gene, plasmid, diphtheria toxin, pancreatic cancer; inodiftagene vixteplasmid; BC-819

Outcome Measures

Primary Outcomes (1)

• Maximal Tolerated Dose (MTD) & Dose Limiting Toxicity (DLT) of Intratumoral Injections of BC-819

  If 2 patients in any cohort experience DLTs, then the next lower dose will be considered the MTD if there is a lower dose cohort. A DLT is defined as grade 3 or greater toxicity judged to be at least possibly related to the investigational products.

  Week 4

Secondary Outcomes (2)

• Tumor Response

  4 weeks

• Tumor Resectability

  5 to 6 weeks

Study Arms (1)

BC-819

EXPERIMENTAL

Intratumoral administration of BC-819

Biological: DTA-H19

Interventions

DTA-H19 BIOLOGICAL

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

Also known as: BC-819

BC-819

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anchiano Therapeutics Israel Ltd.: lead

Study Sites (4)

University of Maryland Medical Center

Baltimore, Maryland, 21201-1595, United States

Location

Hadassah University Hospital

Jerusalem, Israel

Location

Meir Hospital

Kfar Saba, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Monique Ben-Am, M.Sc.
• Organization: BioCancell Ltd.

monique.ben-am@biocancell.com

+972-2-5486533

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2008
• First Posted: July 9, 2008
• Study Start: August 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 20, 2019
• Results First Posted: December 2, 2013

Record last verified: 2019-03

Locations

US (1); IL (3)