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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Transitional Cell, Bladder Neoplasms

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Study End

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

V-0046

NCT ID:

NCT00109655

Start Date:

April 2005

Completion Date:

September 2010

Related Keywords:

  • Carcinoma, Transitional Cell
  • Bladder Neoplasms
  • Superficial Transitional Cell Carcinoma
  • Bacillus Calmette-Guerin (BCG)
  • Superficial Bladder Cancer
  • Gene Therapy
  • Vaccine
  • Adenovirus
  • Carcinoma in situ
  • Urinary Bladder Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location
Baylor College of Medicine Houston, Texas  77030
UCSF Comprehensive Cancer Center San Francisco, California  94115
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Mary Crowley Medical Research Center Dallas, Texas  75246
Columbia University New York, New York  10032-3784
New York Oncology Hematology Albany, New York  12208
Billings Clinic Billings, Montana  59107-7000
BCG Oncology Phoenix, Arizona  85032