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

NCT ID: NCT00040573

Last Updated: 2009-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glioma Brain Neoplasm

Keywords

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Brain neoplasm Clinical trial, phase I/II

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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131I-TM-601

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TransMolecular

INDUSTRY

Sponsor Role lead

Principal Investigators

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Diana M Hablitz, MSNCRNP

Role: STUDY_DIRECTOR

TransMolecular

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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TM601-001

Identifier Type: -

Identifier Source: org_study_id