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NCT02337426 · ClinicalTrials.gov registry record · Phase 1
Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Phase 1 study of Adult Giant Cell Glioblastoma and Adult Gliosarcoma, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02337426: Completed Phase 1 study of Adult Giant Cell Glioblastoma and Adult Gliosarcoma, sponsored by Virginia Commonwealth University.
NCT02337426 is a Phase 1 study of Adult Giant Cell Glioblastoma and Adult Gliosarcoma that has completed, run by Virginia Commonwealth University. The registered enrollment target is 12 participants, below the 43-participant average among 12 other Adult Giant Cell Glioblastoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02337426, a Phase 1 study of Adult Giant Cell Glioblastoma and Adult Gliosarcoma, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given together with temozolomide and radiation therapy(RT) in treating patients with newly diagnosed glioblastoma multiforme (GBM). Dimethyl fumarate may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving dimethyl fumarate with temozolomide and radiation therapy may work better in treating glioblastoma multiforme.
Primary Outcome
Subjects' treatment dosing level, dose modification, DLTs, and evaluability for DLTs and response will be listed and summarized by basic descriptive statistics (such as frequency and proportion).
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Dimethyl Fumarate
Study Locations (1)
Virginia
- Virginia Commonwealth University/Massey Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2015-02-13 |
| Est. Completion | 2017-11-09 |
| Phase | Phase 1 |
What the finished NCT02337426 record still lists
NCT02337426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 43-participant average among 12 other Adult Giant Cell Glioblastoma trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Adult Giant Cell Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT02337426 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT02337426 about?
NCT02337426 is a clinical study titled "Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme". This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given together with temozolomide and radiation therapy(RT) in treating patients with newly diagnosed glioblastoma multiforme (GBM). Dimethyl fumarate may help radiation therapy work better by making tumor cells more ...
What is the current status of trial NCT02337426?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2015-02-13. Estimated completion is 2017-11-09.
What conditions does trial NCT02337426 study?
This clinical trial studies the following conditions: Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Adult Brain Glioblastoma.
What interventions are being tested in trial NCT02337426?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), Dimethyl Fumarate (DRUG).
Who is sponsoring clinical trial NCT02337426?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02337426 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02337426's enrollment target sits among peer trials
12 11th of 12 higher than 1 of 12 other Adult Giant Cell Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adult Giant Cell Glioblastoma 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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