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NCT00124657 · ClinicalTrials.gov registry record · Phase 1
Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT00124657: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT00124657 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00124657, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients with newly diagnosed glioma.
Primary Outcome
DLT was defined as any of the following toxicities attributable to erlotinib therapy: thrombocytopenia grade 3 and 4; neutropenia grade 4; or any grade 3 and 4 non-hematologic toxicity except for grade 3 diarrhea and grade 3 nausea and vomiting lasting ≤48 hours in participants not receiving optimal supportive therapy, grade 3 skin rash, which did not affect normal daily activities, grade 3 fever or nonneutropenic infection, grade 3 seizures, grade 3 weight gain or loss, and grade 3 transaminase
Interventions
- DRUG Erlotinib hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2005-03 |
| Est. Completion | 2014-09 |
| Phase | Phase 1 |
What the finished NCT00124657 record still lists
NCT00124657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Erlotinib hydrochloride is the first listed.
NCT00124657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00124657 about?
NCT00124657 is a clinical study titled "Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma". RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation th...
What is the current status of trial NCT00124657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2005-03. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00124657?
The interventions under investigation include: Erlotinib hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00124657?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00124657's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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