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NCT00876993 · ClinicalTrials.gov registry record · Phase 1
Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors
A Phase 1 study, sponsored by Johns Hopkins All Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00876993: Completed Phase 1 study, sponsored by Johns Hopkins All Children's Hospital.
NCT00876993 is a Phase 1 study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00876993, a Phase 1 study, has completed, sponsored by Johns Hopkins All Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second most common cause of cancer in pediatrics and the leading cause of cancer death in children. For children with High Grade Gliomas or with relapsed/refractory brain tumors, new agents in new combinations are needed. Historical data shows that newly diagnosed high grade gliomas 5 year progression free survival is 28-42%. Recurrent malignant gliomas median survival is 3-9 months. Recurrent medulloblastoma's 2 years survival is 9%. This study is a phase I study designed to provide an objective observation of toxicity and establish a maximum tolerated dose of this combination. In addition, this study will observe the response of children with relapsed or refractory central nervous system tumors.
Primary Outcome
Collect and grade the all of the adverse events to evaluate for safety. This data was collected for the first 2 cycles for each participant.
Interventions
- DRUG Bevacizumab
- DRUG Temozolomide
- DRUG Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2008-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT00876993 record still lists
NCT00876993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT00876993 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00876993 about?
NCT00876993 is a clinical study titled "Study of Irinotecan and Bevacizumab With Temozolomide in Refractory/Relapsed Central Nervous System (CNS) Tumors". Bevacizumab, irinotecan, and temozolomide are three agents shown to have promising activity in a variety of central nervous system tumors. No prospective studies have been published or are currently in progress within the major consortiums with this combination of drugs. Brain tumors are the second ...
What is the current status of trial NCT00876993?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2008-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00876993?
The interventions under investigation include: Bevacizumab (DRUG), Temozolomide (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT00876993?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00876993's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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