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NCT00079339 · ClinicalTrials.gov registry record · Phase 1
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
A Phase 1 study of Untreated Childhood Brain Stem Glioma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT00079339: Completed Phase 1 study of Untreated Childhood Brain Stem Glioma, sponsored by National Cancer Institute (NCI).
NCT00079339 is a Phase 1 study of Untreated Childhood Brain Stem Glioma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079339, a Phase 1 study of Untreated Childhood Brain Stem Glioma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib to see how well it works when given together with radiation therapy in treating young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of 1/19/06)
Primary Outcome
The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.
Conditions Studied
Interventions
- RADIATION radiation therapy
- DRUG tipifarnib
Study Locations (1)
Tennessee
- Pediatric Brain Tumor Consortium - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
What the finished NCT00079339 record still lists
NCT00079339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Untreated Childhood Brain Stem Glioma appearing as the primary indexed condition, and to 2 interventions - of which radiation therapy is the first listed.
NCT00079339 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00079339 about?
NCT00079339 is a clinical study titled "Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma". Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cell...
What is the current status of trial NCT00079339?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2004-01. Estimated completion is 2009-11.
What conditions does trial NCT00079339 study?
This clinical trial studies the following conditions: Untreated Childhood Brain Stem Glioma.
What interventions are being tested in trial NCT00079339?
The interventions under investigation include: radiation therapy (RADIATION), tipifarnib (DRUG).
Who is sponsoring clinical trial NCT00079339?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00079339 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00079339's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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