Phase 2b, Trial of Intravesical DTA-H19/PEI in Patients With Intermediate-Risk Superficial Bladder Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BioCancell Ltd.
ClinicalTrials.gov Identifier:
NCT00595088
First received: January 7, 2008
Last updated: July 16, 2014
Last verified: July 2014
Results First Received: June 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Superficial Bladder Cancer
Intervention: Biological: BC-819/PEI

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient first visit 12 Feb 2008, Last patient first visit 19 Sep 2012. All patients were recruited at the medical sites

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients had to be H19 positive to be recruited

Reporting Groups
  Description
20 mg of BC-819/PEI Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.

Participant Flow:   Overall Study
    20 mg of BC-819/PEI  
STARTED     47  
COMPLETED     7 [1]
NOT COMPLETED     40  
[1] 5 patients ongoing, 7 completed the study (week 46)and 35 withdrew prematurely



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
20 mg of BC-819/PEI Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.

Baseline Measures
    20 mg of BC-819/PEI  
Number of Participants  
[units: participants]
  47  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     31  
Gender [1]
[units: participants]
 
Female     11  
Male     36  
Region of Enrollment  
[units: participants]
 
United States     8  
Israel     39  
[1] 36 males and 11 females



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Tumor Response Defined as the Absence of New Tumors   [ Time Frame: 9 Weeks ]

2.  Secondary:   Time to Tumor Recurrence   [ Time Frame: 46 Weeks ]

3.  Secondary:   Ablative Effect on a Marker Tumor   [ Time Frame: 9 weeks ]

4.  Secondary:   Safety   [ Time Frame: 9 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sarel Halachmi
Organization: Bnai Zion Medical Center
phone: +97248359542
e-mail: sarel.halachmi@b-zion.org.il


No publications provided


Responsible Party: BioCancell Ltd.
ClinicalTrials.gov Identifier: NCT00595088     History of Changes
Other Study ID Numbers: BC-07-01.CTIL
Study First Received: January 7, 2008
Results First Received: June 16, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health