- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00040573
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
March 30, 2009 updated by: TransMolecular
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.
Study Overview
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 Type
Interventional
Enrollment
18
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294-3295
- University of Alabama at Birmingham
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California
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Duarte, California, United States, 91010-3000
- City of Hope
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Missouri
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St. Louis, Missouri, United States, 63110-0250
- Saint Louis University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Diana M Hablitz, MSNCRNP, TransMolecular
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Study Completion
August 1, 2003
Study Registration Dates
First Submitted
June 29, 2002
First Submitted That Met QC Criteria
July 1, 2002
First Posted (Estimate)
July 2, 2002
Study Record Updates
Last Update Posted (Estimate)
March 31, 2009
Last Update Submitted That Met QC Criteria
March 30, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Glioma
- Brain Neoplasms
Other Study ID Numbers
- TM601-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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