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NCT01233492

Boron Phenylalanine With or Without Mannitol in Treating Patients With Glioblastoma Multiforme

A Cancer Research UK Pharmacokinetic Study of BPA in Patients With High Grade Glioma to Optimize Uptake Parameters for Clinical Trials of BNCT
Cancer Research UK·Phase 1·ClinicalTrials.gov·drugTerminated
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Study focus
Disease/Condition
Brain and Central Nervous System Tumors
Drug/Device/Intervention
boron phenylalanine
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Cancer Research UK
Location
Birmingham,Birmingham, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Oct 01, 2007
End date
Sep 01, 2013
Enrollment
36 participants
Primary outcome

Optimal dose of boron phenylalanine (BPA),Causality of each adverse event to BPA and grading severity according to NCI CTCAE Version 3.0,Pharmacokinetic (PK) parameters used to construct a PK model with the aim of being able to predict boron up-take by tumor and normal brain tissue

Summary

RATIONALE: Giving boron phenylalanine in different ways and measuring it in tissue in
 patients with glioblastoma multiforme may help in planning better radiation therapy, such as
 boron neutron capture therapy, for patients in the future.
 
 PURPOSE: This phase I trial is studying the side effects, best dose boron phenylalanine, and
 best way of giving it with or without mannitol in treating patients with glioblastoma
 multiforme.

ICD-10 classifications
Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous systemMalignant neoplasm: Central nervous system, unspecifiedBenign neoplasm of brain and other parts of central nervous systemMalignant neoplasm of brainSecondary malignant neoplasm of other and unspecified parts of nervous system
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT01233492
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT01233492 through Pure Global AI's free database. This Phase 1 trial is sponsored by Cancer Research UK and is currently Terminated. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.