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Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
This study has been completed.
Study NCT00040573   Information provided by TransMolecular
First Received: June 29, 2002   Last Updated: March 30, 2009   History of Changes

June 29, 2002
March 30, 2009
June 2002
 
 
 
Complete list of historical versions of study NCT00040573 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.

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.

Phase I, Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Glioma
  • Brain Neoplasm
Drug: 131I-TM-601
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
18
August 2003
 
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00040573
 
TM601-001
TransMolecular
 
Study Director: Diana M Hablitz, MSNCRNP TransMolecular
TransMolecular
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP