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NCT03657576 · ClinicalTrials.gov registry record · Phase 1
Trial of C134 in Patients With Recurrent GBM
A Phase 1 study of Glioblastoma Multiforme of Brain and Anaplastic Astrocytoma of Brain, sponsored by University of Alabama at Birmingham.
- Active
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT03657576: Active Phase 1 study of Glioblastoma Multiforme of Brain and Anaplastic Astrocytoma of Brain, sponsored by University of Alabama at Birmingham.
NCT03657576 is a Phase 1 study of Glioblastoma Multiforme of Brain and Anaplastic Astrocytoma of Brain that is active but no longer recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 19 participants, below the 157-participant average among 11 other Glioblastoma Multiforme of Brain trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657576, a Phase 1 study of Glioblastoma Multiforme of Brain and Anaplastic Astrocytoma of Brain, is active but no longer recruiting, sponsored by University of Alabama at Birmingham.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this project is to obtain safety information in small groups of individuals, scheduled to receive escalating doses of C134, a cancer killing virus (HSV-1) that has been genetically engineered to safely replicate and kill glioma tumor cells. Safety will be assessed at each dose level before proceeding to the next dose level. A special statistical technique called the Continual Reassessment Method (CRM) will be used to determine when higher doses of virus can be administered. Other objectives of the study include characterization of the activity of C134 after inoculation into the tumor and of the local and systemic immune responses to C134. Patients will also be followed with MRI scans for potential clinical response to C134. The clinical strategy takes advantage of the virus' ability to infect and kill tumor cells while making new virus within the tumors cells; a critical enhancement of this effect is accomplished by the induction of an anti-tumor immune response; both effects are produced by the IRS-1 gene that was placed into the virus by genetic engineering. An additional important component of the research are systematic assessments of the quality of life on treated patients.
Primary Outcome
Dose modifications will utilize a modified Continual Reassessment Method (CRM) for each successive subject until an MTD or the maximal planned dose is reached.
Conditions Studied
Interventions
- BIOLOGICAL C134
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-09-23 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
What the registry record for NCT03657576 still lists
NCT03657576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 157-participant average among 11 other Glioblastoma Multiforme of Brain trials with a reported enrollment target (88% lower).
The record links to 3 conditions, with Glioblastoma Multiforme of Brain appearing as the primary indexed condition, and to 1 intervention - of which C134 is the first listed.
NCT03657576 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT03657576 about?
NCT03657576 is a clinical study titled "Trial of C134 in Patients With Recurrent GBM". The purpose of this project is to obtain safety information in small groups of individuals, scheduled to receive escalating doses of C134, a cancer killing virus (HSV-1) that has been genetically engineered to safely replicate and kill glioma tumor cells. Safety will be assessed at each dose level b...
What is the current status of trial NCT03657576?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2019-09-23. Estimated completion is 2026-09.
What conditions does trial NCT03657576 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme of Brain, Anaplastic Astrocytoma of Brain, Gliosarcoma of Brain.
What interventions are being tested in trial NCT03657576?
The interventions under investigation include: C134 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03657576?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03657576 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03657576's enrollment target sits among peer trials
19 10th of 11 higher than 2 of 11 other Glioblastoma Multiforme of Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme of Brain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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