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NCT00006450 · ClinicalTrials.gov registry record · Phase 2
Phenylbutyrate to Treat Children With Progressive or Recurrent Brain Tumors
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00006450: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00006450 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006450, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of treating brain tumors in children with a continuous infusion of phenylbutyrate. A breakdown product of this drug, phenylacetate, is normally found in low concentrations in the blood. At much higher concentrations, phenylbutyrate and phenylacetate are active against cancer in animals. Patients between 2 and 21 years old with a brain tumor that has progressed or recurred after radiation or chemotherapy, including bone marrow transplant, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, magnetic resonance imaging (MRI) or computerized tomography (CT) of the head and, if needed, a spinal fluid test and bone marrow test. Study participants will have a continuous infusion of phenylbutyrate for two 28-day cycles-every day, 24 hours a day, 7 days a week. The medicine will be infused through a thin tube (catheter) placed in a large vein in the upper chest, delivered through a portable infusion pump. Patients will be hospitalized for at least 3 days when the treatment begins. If there are no side effects at that time, the infusions can continue on an outpatient basis. The patient or care giver will receive the medicine in 4-day supplies and will be taught how to change the bag and tubing daily for drug administration, as well as how to use the infusion pump. Patients will be monitored with weekly blood tests to look for side effects and measure blood levels of phenylbutyrate. They will have a physical examination at least once a week. At the end of the second 28-day cycle, patients will have a CT or MRI scan to evaluate the tumor's response to treatment. Patients whose tumor has grown will stop treatment and come off the study. Those whose tumor has remained stable or shrunk may continue phenylbutyrate as long as the treatment is beneficial and there are no serious side effects. CT or MRI scans will be done after every 2 cycles (or sooner if needed
Interventions
- DRUG Phenylbutyrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2000-11 |
| Est. Completion | 2002-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006450
The ClinicalTrials.gov registry entry for NCT00006450 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Phenylbutyrate is the first listed.
NCT00006450 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006450 about?
NCT00006450 is a clinical study titled "Phenylbutyrate to Treat Children With Progressive or Recurrent Brain Tumors". This study will examine the safety and effectiveness of treating brain tumors in children with a continuous infusion of phenylbutyrate. A breakdown product of this drug, phenylacetate, is normally found in low concentrations in the blood. At much higher concentrations, phenylbutyrate and phenylaceta...
What is the current status of trial NCT00006450?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2000-11. Estimated completion is 2002-07.
What interventions are being tested in trial NCT00006450?
The interventions under investigation include: Phenylbutyrate (DRUG).
Who is sponsoring clinical trial NCT00006450?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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