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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 is a Phase 1 study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 26 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00876993
The ClinicalTrials.gov registry entry for NCT00876993 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins All Children's Hospital, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT00876993 reports 0 study locations.
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.
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