Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.

TransMolecular18 enrolled

Overview

This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.

This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glioma Brain Neoplasm

Interventions

131I-TM-601DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* Patient must have given informed consent * Patient must have histologically confirmed supratentorial malignant glioma * Patients must have recovered from toxicity of prior therapy * Patients must be eligble for resection of the recurrent tumor

Locations (3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

Saint Louis University

St Louis, Missouri, United States

Data from ClinicalTrials.gov

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