At a glance
ClinicalIndex Comparison RecordPhase 1Completed
Drug / intervention
phenylbutyratedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I and Pharmacokinetic Trial of Phenylbutyrate Given as a Continuous Infusion in Pediatric Patients With Refractory Malignancy
In Brief
A Phase 1 clinical trial evaluating phenylbutyrate for Brain Neoplasms and Neuroblastoma. Completed, across 1 site.
Detailed Summary
This is a pharmacokinetic trial. Patients receive phenylbutyrate through a central venous catheter for each 28 day cycle. The first several days of drug administration should be inpatient. Cycles may be repeated if there is no tumor progression or dose limiting toxicities (DLT). There are no breaks between cycles. Once a minimum of 3 patients have completed at least 4 weeks of therapy without DLT, new patients will be entered at the next dose level.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Neoplasms, Neuroblastoma
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 1996
Study CompletionOct 2000
First PostedDec 2002
TodayJul 2026
First PostedDec 10, 2002
Enrollment StartDec 1, 1996
Study CompletionOct 1, 2000
TodayJul 2, 2026
Posted 23.6 years ago
Interventions
phenylbutyratedrug