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

Carcinoma, Transitional Cell Clinical Trial

Official title:

A Phase 1 Dose-Escalation Trial of Intravesical CG0070 for Superficial Transitional Cell Carcinoma of the Bladder After Bacillus Calmette-Guerin Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00109655
• Other study ID #: V-0046
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 2, 2005
• Last updated: October 1, 2008
• Start date: April 2005
• Est. completion date: September 2010

Study information

• Verified date: October 2008
• Source: Cell Genesys
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The main purpose of this research study is to evaluate the safety and dosing of CG0070.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: September 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Neoplasms
• Carcinoma
• Carcinoma, Transitional Cell
• Urinary Bladder Neoplasms

Intervention

Biological:
• Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder

Locations

Country	Name	City	State
Canada	Male/Female Health and Research Centre	Barrie	Ontario
Canada	The Fe/Male Health Centre	Oakville	Ontario
United States	New York Oncology Hematology	Albany	New York
United States	Billings Clinic	Billings	Montana
United States	Mary Crowley Medical Research Center	Dallas	Texas
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Columbia University	New York	New York
United States	BCG Oncology	Phoenix	Arizona
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Cell Genesys

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration		Study End	Yes
Secondary	Assessment of the amount of CG0070 in the urine and blood over time by PCR		Study End	Yes

External Links

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