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Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure

Primary Purpose

Carcinoma, Transitional Cell, Bladder Neoplasms

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Oncolytic adenovirus (serotype 5) - CG0070
Sponsored by
Cell Genesys
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell focused on measuring Superficial Transitional Cell Carcinoma, Bacillus Calmette-Guerin (BCG), Superficial Bladder Cancer, Gene Therapy, Vaccine, Adenovirus, Carcinoma in situ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease. Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment ECOG performance status 0-1 Adequate bone marrow, renal, liver and coagulation function Exclusion Criteria: Pregnant or nursing HIV positive Use of anticoagulants such as coumadin or heparin History of bleeding disorder Active systemic autoimmune disease or chronic immunodeficiency Prior gene therapy Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume

Sites / Locations

  • BCG Oncology
  • UCSF Comprehensive Cancer Center
  • Billings Clinic
  • New York Oncology Hematology
  • Columbia University
  • Cancer Centers of the Carolinas
  • Mary Crowley Medical Research Center
  • Baylor College of Medicine
  • Male/Female Health and Research Centre
  • The Fe/Male Health Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration

Secondary Outcome Measures

Assessment of the amount of CG0070 in the urine and blood over time by PCR

Full Information

First Posted
May 2, 2005
Last Updated
October 1, 2008
Sponsor
Cell Genesys
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1. Study Identification

Unique Protocol Identification Number
NCT00109655
Brief Title
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
Official Title
A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Cell Genesys

4. Oversight

5. Study Description

Brief Summary
The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Detailed Description
Cohorts of three to six patients will be assigned to receive intravesical (into the bladder) administration of CG0070 either Weekly or Every 4 Weeks for up to a total of 6 doses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Transitional Cell, Bladder Neoplasms
Keywords
Superficial Transitional Cell Carcinoma, Bacillus Calmette-Guerin (BCG), Superficial Bladder Cancer, Gene Therapy, Vaccine, Adenovirus, Carcinoma in situ

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Oncolytic adenovirus (serotype 5) - CG0070
Intervention Description
Intravesical administration of CG0070 (in suspension) directly into the bladder
Primary Outcome Measure Information:
Title
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
Time Frame
Study End
Secondary Outcome Measure Information:
Title
Assessment of the amount of CG0070 in the urine and blood over time by PCR
Time Frame
Study End

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High grade non-muscle invasive bladder cancer (stages Ta, T1 and/or CIS - carcinoma in situ). High grade being defined as G2 or G3 disease. Failure of at least one prior treatment with BCG, defined as evidence of TCC on cystoscopic exam and biopsy or cystoscopic exam and urine cytology at least 6 weeks from last BCG treatment ECOG performance status 0-1 Adequate bone marrow, renal, liver and coagulation function Exclusion Criteria: Pregnant or nursing HIV positive Use of anticoagulants such as coumadin or heparin History of bleeding disorder Active systemic autoimmune disease or chronic immunodeficiency Prior gene therapy Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Facility Information:
Facility Name
BCG Oncology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Male/Female Health and Research Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
The Fe/Male Health Centre
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.cellgenesys.com
Description
Related Info

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Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure

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