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NCT00040573 Clinical Trial

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

Glioma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00040573
Other study ID # TM601-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 29, 2002
Last updated March 30, 2009
Start date June 2002
Est. completion date August 2003

Study information
Verified date March 2009
Source TransMolecular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 131I-TM-601

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States City of Hope Duarte California
United States Saint Louis University St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
TransMolecular

Country where clinical trial is conducted

United States, 

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