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

Cell Genesys

Status and phase: Unknown; Phase 1

Conditions: Carcinoma, Transitional Cell; Bladder Neoplasms

Treatments: Biological: Oncolytic adenovirus (serotype 5) - CG0070

Study type: Interventional

Funder types: Industry

Identifiers

NCT00109655

V-0046

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 1 patient group

1

Experimental group

Treatment:

Biological: Oncolytic adenovirus (serotype 5) - CG0070