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

This study has been completed.

First Received: June 29, 2002 Last Updated: March 30, 2009 History of Changes

Sponsored by:	TransMolecular
Information provided by:	TransMolecular
ClinicalTrials.gov Identifier:	NCT00040573

Purpose

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 I Phase II

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040573

Locations

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

TransMolecular

Investigators

Study Director:

Diana M Hablitz, MSNCRNP

TransMolecular

More Information

No publications provided

Study ID Numbers:	TM601-001
Study First Received:	June 29, 2002
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00040573 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by TransMolecular:

Brain neoplasm
Clinical trial, phase I/II

Study placed in the following topic categories:

Neuroectodermal Tumors
Brain Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Central Nervous System Diseases
Central Nervous System Neoplasms

Glioma
Brain Diseases
Nervous System Neoplasms
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Brain Neoplasms
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009