Phase 1/2a Study of DTA-H19 in Advanced Stage Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioCancell Ltd.
ClinicalTrials.gov Identifier:
NCT00826150
First received: January 18, 2009
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of DTA-H19 administered intraperitoneally (IP) in subjects with advanced stage ovarian cancer, or primary peritoneal carcinoma


Condition Intervention Phase
Ovarian Cancer
Biological: BC-819
Phase 1
Phase 2

Study Type: Interventional
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 Intraperitoneal Administration of DTA-H19 in Subjects With Advanced Stage Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by BioCancell Ltd.:

Primary Outcome Measures:
  • maximum tolerated dose of DTA-H19 given intraperitoneally [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • progression-free survival [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BC-819
BC-819 60, 120 and 240 mg IP administration
Biological: BC-819

Cohort #1: 60 mg IP weekly for 3 weeks, one week rest, then repeat for 2 more courses / 60 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Cohort #2: 120 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Cohort #3: 240 mg IP weekly for 3 weeks, four week rest, then repeat for 1 more course.

Other Name: DTA-H19

Detailed Description:

This is a Phase 1/2a, open label, dose escalation, repeat dose study in 11 subjects with recurrent, platinum resistant advanced stage ovarian cancer or primary peritoneal carcinoma designed to determine the tolerability, safety, quality of life, PK, and preliminary efficacy of DTA-H19 administered intraperitoneally(IP).

Primary Objective: The primary objectives of this study are:

  • To determine the maximum tolerated dose (MTD) of IP DTA-H19; and,
  • To identify any dose limiting toxicities (DLTs).

Secondary Objectives: Secondary objectives of this study are:

  • To determine quality of life of subjects with advanced ovarian cancer, primary peritoneal carcinoma treated with IP DTA-H19;
  • To determine the the reduction in malignant ascites as measured by Ultrasound and change in frequency of parecenteses necessary.
  • To determine the overall survival distribution.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent and be at least 18 years of age.
  • Have histopathologically documented epithelial ovarian carcinoma or primary peritoneal carcinoma with evidence of ascites.
  • Have either a) platinum-refractory disease (i.e. persistent disease following completion of platinum-based primary chemotherapy) and have failed at least primary platinum-based chemotherapy; or b) platinum-resistant recurrent disease and have failed at least one regimen of second line chemotherapy.
  • Be able to tolerate placement of IP catheter.
  • Be at least 2 weeks from last treatment to allow recovery from prior toxicity but in the judgment of the investigator with sufficient time to ensure that the effects of prior treatments will not confound safety evaluations.
  • Have a Karnofsky performance status score of ≥ 70%.
  • Not be of child-bearing potential.
  • Have a life expectancy of ≥ 3 months.
  • Have serum creatinine < 2.0 mg/dL, total bilirubin less than the institution's 3x upper limit of normal (ULN); AST and ALT <= 2.5 x ULN,total albumin ≥ 2.5 g/dL, PT, PTT, 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 or an ascites fluid that is positive for H19 expression.
  • Have screening procedures completed within 6-weeks before starting treatment.
  • No significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina or congestive heart failure.
  • - No plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on this protocol.

Exclusion Criteria:

  • Have evidence of extra abdominal disease with the exception of isolated small nodules (e.g., liver or pulmonary nodules) that are not causing symptoms.
  • Have known brain metastases.
  • Have known HIV infection.
  • Have known active viral or bacterial infections.
  • Have presence of any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol or follow up schedule.
  • Have a medical condition contraindicated for laparotomy, laparoscopy, or surgery.
  • Have significant bowel involvement denoted by persistent grade 3 vomiting (≥6 episodes in 24 hrs; IV fluids, or total parenteral nutrition (TPN) indicated ≥24 hrs) after removal of ascites, inability to tolerate oral diet or medications, requirement for total parenteral nutrition, or recent (past six weeks) episode of bowel obstruction.
  • Have a history of coagulopathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826150

Locations
Israel
The Edith Wolfson Medical Center
Holon, Israel
Hadassah University Hospital
Jerusalem, Israel
Meir Hospital
Kfar Saba, Israel
Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
BioCancell Ltd.
Investigators
Principal Investigator: Tally Levy, M.D. The Edith Wolfson Medical Center
Principal Investigator: David Edelman, MD Hadassah University Hospital
Principal Investigator: Ami Fishman, MD Meir Medical Center
Principal Investigator: Eitan Rami, MD. Rabin Medical Center
Principal Investigator: Ofer Lavie, M.D. Carmel Medical Center
Principal Investigator: Ronnie Shapira-Frommer, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: BioCancell Ltd.
ClinicalTrials.gov Identifier: NCT00826150     History of Changes
Other Study ID Numbers: BC-08-01
Study First Received: January 18, 2009
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by BioCancell Ltd.:
ovarian cancer
H19 gene
plasmid

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 22, 2014