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NCT02663271 · ClinicalTrials.gov registry record · Phase 2
TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma
A Phase 2 study, sponsored by University of Florida.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02663271 is a Phase 2 study that was terminated before completion, run by University of Florida. The registered enrollment target is 10 participants.
The verdict
NCT02663271, a Phase 2 study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Novocure has shown that when properly tuned, very low intensity, intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM Therapy) is a portable battery operated device, which produces TTFields within the human body by means of surface transducer arrays. The TTFields are applied to the patient by means of surface transducer arrays that are electrically insulated, so that resistively coupled electric currents are not delivered to the patient. Optune is currently FDA-approved as a single modality treatment for recurrent GBM when both surgical and radiotherapy options have been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM. This research study is being performed to determine whether or not TTFields combined with pulsed bevacizumab treatment increases overall survival in patients with bevacizumab-refractory GBM compared to historical controls treated with continuous bevacizumab alone or in combination with other chemotherapy.
Interventions
- DRUG Bevacizumab
- OTHER Quality of Life Questionnaires
- DEVICE Optune
- OTHER Brain MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-12-19 |
| Est. Completion | 2021-06-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02663271
The ClinicalTrials.gov registry entry for NCT02663271 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.
NCT02663271 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02663271 about?
NCT02663271 is a clinical study titled "TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma". Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Novocure has shown that when...
What is the current status of trial NCT02663271?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2016-12-19. Estimated completion is 2021-06-11.
What interventions are being tested in trial NCT02663271?
The interventions under investigation include: Bevacizumab (DRUG), Quality of Life Questionnaires (OTHER), Optune (DEVICE), Brain MRI (OTHER).
Who is sponsoring clinical trial NCT02663271?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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