Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer
Public ClinicalTrials.gov record NCT01438112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Integrated Phase II/III, Open Label, Randomized and Controlled Study of the Safety and Efficacy of CG0070 Adenovirus Vector Expressing GM-CSF in Patients With NMIBC With Carcinoma In Situ Disease Who Have Failed BCG
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs.
Study identification
- NCT ID
- NCT01438112
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Interventions
- CG0070 Adenovirus Vector Biological
- Control Arm: Quadruple Choice Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2014
- Primary completion
- May 31, 2016
- Completion
- May 31, 2016
- Last update posted
- Apr 13, 2021
2014 – 2016
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| BCG Oncology | Phoenix | Arizona | 85032-2129 | — |
| University of California, San Diego- Moores Cancer Center | La Jolla | California | 92093 | — |
| UCLA Institute of Urological Oncology | Los Angeles | California | 90024 | — |
| University of California, Davis- Cancer Center | Sacramento | California | 95817 | — |
| University of Chicago, Department of Surgery, Section of Urology | Chicago | Illinois | 60637 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Vanderbilt University Medical Center Department of Urologic Surgery | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01438112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01438112 live on ClinicalTrials.gov.