NCT00826150

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 21, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

June 13, 2019

Completed
Last Updated

June 13, 2019

Status Verified

May 1, 2019

Enrollment Period

2.7 years

First QC Date

January 18, 2009

Results QC Date

August 22, 2013

Last Update Submit

May 21, 2019

Conditions

Ovarian Cancer

Keywords

ovarian cancerH19 geneplasmidinodiftagene vixteplasmid

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Dose-Limiting Toxicities

    A dose limiting toxicity (DLT) was defined as any grade 3 or greater non-hematologic AE by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). If one subject in a cohort experienced a DLT, then three additional subjects had to be enrolled to that cohort unless a second subject in that cohort experiences a DLT. The next lower dose was to be considered the MTD.

    8 weeks

Secondary Outcomes (8)

  • Overall Survival in ITT Population

    17.5 months

  • Solid Tumor Response

    6 weeks

  • Systemic BC-819 Pharmacokinetics (PK) by Treatment - T1/2 (Hours)

    Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion

  • Systemic BC-819 Pharmacokinetics (PK) - Maximum Observed Plasma Concentration (Cmax)

    Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion

  • Systemic BC-819 Pharmacokinetics (PK) by Treatment - Tmax (Hours)

    Before the start of the infusion of BC-819 and 2, 4, 6, 8, 24, and 48 hours after the start of the infusion

  • +3 more secondary outcomes

Study Arms (1)

BC-819

EXPERIMENTAL

BC-819 60, 120 and 240 mg IP administration

Biological: BC-819

Interventions

BC-819BIOLOGICAL

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.

Also known as: DTA-H19
BC-819

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Edith Wolfson Medical Center

Holon, Israel

Location

Hadassah University Hospital

Jerusalem, Israel

Location

Meir Hospital

Kfar Saba, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Results Point of Contact

Title
VP Clinical
Organization
BioCancell Ltd.
monique.ben-am@biocancell.com
+97225486553

Study Officials

  • 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

    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

January 18, 2009

First Posted

January 21, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 13, 2019

Results First Posted

June 13, 2019

Record last verified: 2019-05

Locations

IL(4)