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

Cell Genesys75 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Transitional Cell Bladder Neoplasms

Interventions

Oncolytic adenovirus (serotype 5) - CG0070BIOLOGICAL

Intravesical administration of CG0070 (in suspension) directly into the bladder

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

BCG Oncology

Phoenix, Arizona, United States

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Billings Clinic

Billings, Montana, United States

Outcomes

Primary Outcomes

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

Time frame: Study End

Secondary Outcomes

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

Time frame: Study End

Data from ClinicalTrials.gov

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