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NCT00822887 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT00822887 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 13 participants.
The verdict
NCT00822887, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy. This study drug has been designed to block certain chemical pathways that stimulate tumor to grow. The study drug has been shown to slow the growth of a number of types of cancers. This will be a dose escalation study. A dose escalation study means that successive groups of patients will receive higher doses of the study drug. There are three dose levels. The dose of the study drug received will depend on the stage the study has reached at the time a patient decides to participate. In addition to taking the study drug patients will also receive radiation therapy to the brain tumor for 3 days. Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days after radiation completed) dose limiting toxicities.
Interventions
- DRUG Vandetanib
- RADIATION Fractionated Stereotactic Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00822887
The ClinicalTrials.gov registry entry for NCT00822887 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vandetanib is the first listed.
NCT00822887 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00822887 about?
NCT00822887 is a clinical study titled "Dose Escalation Study of Vandetanib With Hypofractionated Stereotactic Radiotherapy in Recurrent Malignant Gliomas". The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy. This study drug has been designed to block certain chemical pathways that stimulate tumor to grow. The study drug has been shown to slow the growth of a number of types of ...
What is the current status of trial NCT00822887?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2007-03. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00822887?
The interventions under investigation include: Vandetanib (DRUG), Fractionated Stereotactic Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT00822887?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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