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NCT00513162 · ClinicalTrials.gov registry record · Phase 1
Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00513162: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00513162 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00513162, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
Primary Objective: * Determine the interindividual range and median of individual maximum tolerated doses of valproic acid administered as one time evening dose in conjunction with a dose oral etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four different age groups. Secondary Objectives: * Determine the qualitative and quantitative toxicity and reversibility of toxicity of valproic acid in conjunction with oral etoposide, * To investigate the clinical pharmacokinetics of valproic acid when given in conjunction with oral etoposide, * To describe quality of life of patients with relapsed, or progressive central and peripheral nervous system tumors when treated with oral valproic acid and etoposide, * To observe and describe the response pattern of progressive central nervous system tumors treated with oral valproic acid and etoposide, * To observe and describe event free survival time and overall survival time of patients with relapsed, or progressive central nervous system tumors when treated with oral valproic acid and etoposide, * To determine if histone deacetylase activity and topoisomerase expression in lymphocytes of patients is related to valproic acid levels, and * To determine, if the individual maximal tolerated dose (iMTD) depends on the initial performance status of the patient in the beginning of the treatment.
Interventions
- DRUG Etoposide
- DRUG Valproate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-07 |
| Phase | Phase 1 |
What the finished NCT00513162 record still lists
NCT00513162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Etoposide is the first listed.
NCT00513162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00513162 about?
NCT00513162 is a clinical study titled "Valproate and Etoposide for Patients With Neuronal Tumors and Brain Metastases". Primary Objective: * Determine the interindividual range and median of individual maximum tolerated doses of valproic acid administered as one time evening dose in conjunction with a dose oral etoposide (50 mg/m2/day for children, but only 25mg/m2/day for adults to start) for four different age gro...
What is the current status of trial NCT00513162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2007-07.
What interventions are being tested in trial NCT00513162?
The interventions under investigation include: Etoposide (DRUG), Valproate (DRUG).
Who is sponsoring clinical trial NCT00513162?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00513162's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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