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

October 1, 2008 updated by: Cell Genesys

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Male/Female Health and Research Centre
      • Oakville, Ontario, Canada, L6H 3P1
        • The Fe/Male Health Centre
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • BCG Oncology
    • California
      • San Francisco, California, United States, 94143
        • UCSF Comprehensive Cancer Center
    • Montana
      • Billings, Montana, United States, 59107
        • Billings Clinic
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology
      • New York, New York, United States, 10032
        • Columbia University
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Biological: Oncolytic adenovirus (serotype 5) - CG0070
Intravesical administration of CG0070 (in suspension) directly into the bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum-tolerated or maximum feasible dose in single and multidose regimens of CG0070 by intravesical administration
Time Frame: Study End
Study End

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the amount of CG0070 in the urine and blood over time by PCR
Time Frame: Study End
Study End

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cell Genesys

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ANTICIPATED)

October 1, 2008

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

May 2, 2005

First Submitted That Met QC Criteria

May 2, 2005

First Posted (ESTIMATE)

May 3, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2008

Last Update Submitted That Met QC Criteria

October 1, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V-0046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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