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Boron Phenylalanine With or Without Mannitol in Treating Patients With Glioblastoma Multiforme - Trial NCT01233492

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.

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NCT01233492
Phase 1
Terminated
drug
Trial Details
ClinicalTrials.gov โ€ข NCT01233492
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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

Study Focus

boron phenylalanine

Interventional

drug

Sponsor & Location

Cancer Research UK

Birmingham,Birmingham, United Kingdom

Timeline & Enrollment

Phase 1

Oct 01, 2007

Sep 01, 2013

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 system
Malignant neoplasm: Central nervous system, unspecified
Benign neoplasm of brain and other parts of central nervous system
Malignant neoplasm of brain
Secondary malignant neoplasm of other and unspecified parts of nervous system

Data Source

ClinicalTrials.gov

NCT01233492

Non-Device Trial