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NCT01324635 · ClinicalTrials.gov registry record · Phase 1
Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01324635 is a Phase 1 study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 17 participants.
The verdict
NCT01324635, a Phase 1 study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is an open label phase I clinical trial with two arms, representing single and fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for 2 weeks. Panobinostat will be dose-escalated independently in each arm. There is no intra-patient dose escalation. Recurrent gliomas (Arm A) will be treated according to the Jefferson protocol for re-irradiation, 10 fractions each of 3.5Gy delivered over 2 weeks. Panobinostat will be administered orally three times a week for 2 weeks, starting on day 1 or 2 of radiation therapy. High-grade meningiomas (Arm A) will be treated with 6 weeks/30 fractions of fractionated radiation therapy, to a total dose of between 54 Gy and 60 Gy in fractions of either 1.8Gy or 2Gy. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of 1st fraction of radiation. Large brain metastases (Arm B) will be treated with a single fraction of radiosurgery. Panobinostat will be administered orally three times a week for 2 weeks, starting on the day of radiation. The radiosurgery may be delivered by either LINAC, gamma-knife, cyber-knife or tomotherapy technology.
Interventions
- RADIATION Stereotactic radiosurgery
- RADIATION Stereotactic body radiation therapy
- PROCEDURE Quality-of-life assessment
- DRUG Panobinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01324635
The ClinicalTrials.gov registry entry for NCT01324635 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Stereotactic radiosurgery is the first listed.
NCT01324635 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01324635 about?
NCT01324635 is a clinical study titled "Panobinostat and Stereotactic Radiation Therapy in Treating Patients With Brain Tumors". This is an open label phase I clinical trial with two arms, representing single and fractionated radiation therapy (Figure 4.1). Within each arm the radiation dose is pre-determined and not escalated. Panobinostat will be administered orally 3 times a week for 2 weeks. Panobinostat will be dose-esca...
What is the current status of trial NCT01324635?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2012-05. Estimated completion is 2016-10.
What interventions are being tested in trial NCT01324635?
The interventions under investigation include: Stereotactic radiosurgery (RADIATION), Stereotactic body radiation therapy (RADIATION), Quality-of-life assessment (PROCEDURE), Panobinostat (DRUG).
Who is sponsoring clinical trial NCT01324635?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
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