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

Tracking Information

First Received Date ^ICMJE

June 29, 2002

Last Updated Date

March 30, 2009

Start Date ^ICMJE

June 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00040573 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.

Brief 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.

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.

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Glioma
Brain Neoplasm

Intervention ^ICMJE

Drug: 131I-TM-601

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00040573

Responsible Party

Study ID Numbers ^ICMJE

TM601-001

Study Sponsor ^ICMJE

TransMolecular

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Diana M Hablitz, MSNCRNP

TransMolecular

Information Provided By

TransMolecular

Verification Date

March 2009

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