Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
This study has been completed.
Sponsor:
TransMolecular
Information provided by:
TransMolecular
ClinicalTrials.gov Identifier:
NCT00040573
First received: June 29, 2002
Last updated: March 30, 2009
Last verified: March 2009
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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 |
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
| 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 Neoplasms Glioma Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 23, 2013