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NCT00095940 · ClinicalTrials.gov registry record · Phase 1
Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors
A Phase 1 study of Recurrent Childhood Ependymoma and Recurrent Childhood Medulloblastoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT00095940: Completed Phase 1 study of Recurrent Childhood Ependymoma and Recurrent Childhood Medulloblastoma, sponsored by National Cancer Institute (NCI).
NCT00095940 is a Phase 1 study of Recurrent Childhood Ependymoma and Recurrent Childhood Medulloblastoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 52 participants, above the 34-participant average among 4 other Recurrent Childhood Ependymoma trials with a reported enrollment target (53% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095940, a Phase 1 study of Recurrent Childhood Ependymoma and Recurrent Childhood Medulloblastoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Primary Outcome
Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests m
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- PROCEDURE therapeutic conventional surgery
- OTHER pharmacological study
- PROCEDURE positron emission tomography
- DRUG lapatinib ditosylate
Study Locations (1)
Tennessee
- Pediatric Brain Tumor Consortium - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2004-10 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
What the finished NCT00095940 record still lists
NCT00095940 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, above the 34-participant average among 4 other Recurrent Childhood Ependymoma trials with a reported enrollment target (53% higher).
The record links to 8 conditions, with Recurrent Childhood Ependymoma appearing as the primary indexed condition, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00095940 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00095940 about?
NCT00095940 is a clinical study titled "Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors". This phase I/II trial studies lapatinib to see how well it works in treating young patients with recurrent or refractory central nervous system (CNS) tumors. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
What is the current status of trial NCT00095940?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2004-10. Estimated completion is 2010-07.
What conditions does trial NCT00095940 study?
This clinical trial studies the following conditions: Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Glioblastoma, Recurrent Childhood Anaplastic Astrocytoma.
What interventions are being tested in trial NCT00095940?
The interventions under investigation include: laboratory biomarker analysis (OTHER), therapeutic conventional surgery (PROCEDURE), pharmacological study (OTHER), positron emission tomography (PROCEDURE), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00095940?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00095940 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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