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

This study has been completed.
Sponsor:
Information provided by:
TransMolecular
ClinicalTrials.gov Identifier:
NCT00040573
First received: June 29, 2002
Last updated: March 30, 2009
Last verified: March 2009
  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 1
Phase 2

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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by TransMolecular:
Brain neoplasm
Clinical trial, phase I/II

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 24, 2014