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History of Changes for Study: NCT00109655
Dose-Escalation Study of CG0070 for Bladder Cancer After BCG (Bacillus Calmette-Guerin) Failure
Latest version (submitted October 1, 2008) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 July 18, 2005 Contacts/Locations and Study Status
3 August 25, 2005 Contacts/Locations and Study Status
4 June 22, 2006 Contacts/Locations and Study Status
5 August 11, 2006 Contacts/Locations, Study Design, Eligibility, Study Description and Study Status
6 August 16, 2006 Study Status, Eligibility, Study Design and Study Description
7 May 25, 2007 Contacts/Locations, Study Status and Study Design
8 August 27, 2007 Contacts/Locations, Study Status and Eligibility
9 December 13, 2007 Study Status, Contacts/Locations and Outcome Measures
10 December 20, 2007 Arms and Interventions, Study Status and Sponsor/Collaborators
11 December 21, 2007 Contacts/Locations and Study Status
12 May 22, 2008 Recruitment Status, Study Status and Contacts/Locations
13 October 1, 2008 Recruitment Status and Study Status
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Study NCT00109655
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: V-0046
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2005
Overall Status: Recruiting
Study Start: April 2005
Primary Completion:
Study Completion:
First Submitted: May 2, 2005
First Submitted that
Met QC Criteria:
May 2, 2005
First Posted: May 3, 2005 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Cell Genesys
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The main purpose of this research study is to evaluate the safety and dosing of CG0070.
Detailed Description:
Open or close this module Conditions
Conditions: Carcinoma, Transitional Cell
Bladder Neoplasms
Keywords: Superficial Transitional Cell Carcinoma
Bacillus Calmette-Guerin (BCG)
Superficial Bladder Cancer
Gene Therapy
Vaccine
Adenovirus
Carcinoma in situ
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 36
Open or close this module Arms and Interventions
Intervention Details:
Genetic: Vaccine: CG0070
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Transitional Cell Carcinoma (TCC) Stages Ta, T1 or CIS (carcinoma in situ)
  • 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
  • Radiation therapy or chemotherapy within 4 weeks of treatment
  • Intravesical therapy with other chemotherapy or biological agents within 6 weeks of the first treatment
  • Uncontrolled cystitis, bladder pain, bladder spasms, urinary incontinence, or reduced bladder volume
Open or close this module Contacts/Locations
Locations: United States, South Carolina
Cancer Centers of the Carolinas
[Recruiting]
Greenville, South Carolina, United States, 29605
Contact:Contact: Julie Martin, NP 864-679-3967 Julie.Martin@usoncology.com
Contact:Contact: Judy Rush 864-679-3966 judy.rush@usoncology.com
Contact:Principal Investigator: Joe Stephenson, MD
United States, Texas
Mary Crowley Medical Research Center
[Not yet recruiting]
Dallas, Texas, United States, 75246
Contact:Contact: Candace Branom, RN 214-370-1857
Contact:Contact: John Nemunaitis, MD 214-370-1870
Contact:Principal Investigator: John Nemunaitis, MD
United States, Washington
Virginia Mason Medical Center Urology
[Not yet recruiting]
Seattle, Washington, United States, 98101
Contact:Contact: Kathryn Dahl 206-341-0578
Contact:Contact: John Corman, MD 206-625-7373 Ext. 63348
Contact:Principal Investigator: John Corman, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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