The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
Public ClinicalTrials.gov record NCT02414165. 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
A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process. Funding Source - FDA OOPD
Study identification
- NCT ID
- NCT02414165
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 403 participants
Conditions and interventions
Conditions
Interventions
- Toca 511 Biological
- Toca FC Drug
- Lomustine Drug
- Temozolomide Drug
- Bevacizumab Biological
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Nov 30, 2015 (Actual)
- Primary completion
- May 31, 2019 (Actual)
- Completion
- Dec 20, 2019 (Actual)
- Last update posted
- Feb 7, 2020
2015 – 2019
United States locations
- U.S. sites
- 50
- U.S. states
- 23
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute at Dignity Health St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| University of California, Irvine | Irvine | California | 92868 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| St. Joseph Hospital | Orange | California | 92868 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Stanford University | Stanford | California | 94305 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | — |
| Associated Neurologists of Southern Connecticut | Fairfield | Connecticut | 06824 | — |
| Yale University/Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| University of Florida McKnight Brain Institute | Gainesville | Florida | 32611 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Abbott Northwestern Hospital / Allina Health | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| HCA Midwest / Sarah Cannon | Kansas City | Missouri | 64132 | — |
| Washington University St. Louis | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| JFK Medical Center Neuroscience Institute | Edison | New Jersey | 08820 | — |
| John Theurer Cancer Center at Hackensack University | Hackensack | New Jersey | 07601 | — |
| Overlook Medical Center | Summit | New Jersey | 07901 | — |
| North Shore University Hospital | Lake Success | New York | 11042 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Columbia University | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | — |
| Cincinnati's Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19101 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Sanford Research | Sioux Falls | South Dakota | 57104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Houston Methodist Hospital Outpatient Center | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at Houston (UTHealth) | Houston | Texas | 77030 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Inova Dwight and Martha Schar Cancer Institute | Fairfax | Virginia | 22031 | — |
| Sentara Neurosurgery Specialists | Norfolk | Virginia | 23507 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02414165, 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 Feb 7, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02414165 live on ClinicalTrials.gov.