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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 2, 2002
Last Update Posted: March 31, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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.

Condition Intervention Phase
Glioma Brain Neoplasm Drug: 131I-TM-601 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.

Resource links provided by NLM:

Further study details as provided by TransMolecular:

Estimated Enrollment: 18
Study Start Date: June 2002
Estimated Study Completion Date: August 2003
Detailed Description:
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040573

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3295
United States, California
City of Hope
Duarte, California, United States, 91010-3000
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63110-0250
Sponsors and Collaborators
Study Director: Diana M Hablitz, MSNCRNP TransMolecular
  More Information

ClinicalTrials.gov Identifier: NCT00040573     History of Changes
Other Study ID Numbers: TM601-001
First Submitted: June 29, 2002
First Posted: July 2, 2002
Last Update Posted: March 31, 2009
Last Verified: March 2009

Keywords provided by TransMolecular:
Brain neoplasm
Clinical trial, phase I/II

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases