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

NCT ID: NCT00826150

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-02-29

Brief Summary

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

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BC-819

BC-819 60, 120 and 240 mg IP administration

Group Type: EXPERIMENTAL

BC-819

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

DTA-H19

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Anchiano Therapeutics Israel Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tally Levy, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Edith Wolfson Medical Center

David Edelman, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah University Hospital

Ami Fishman, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Eitan Rami, MD.

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Ofer Lavie, M.D.

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Ronnie Shapira-Frommer, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

The Edith Wolfson Medical Center

Holon, , Israel

Hadassah University Hospital

Jerusalem, , Israel

Meir Hospital

Kfar Saba, , Israel

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

BC-08-01

Identifier Type: -

Identifier Source: org_study_id