Clinical Trials Logo
  1. Home
  2. Glioma
  3. NCT00040573
  4. Details
NCT00040573 Clinical Trial

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

Glioma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00040573
Other study ID # TM601-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 29, 2002
Last updated March 30, 2009
Start date June 2002
Est. completion date August 2003

Study information
Verified date March 2009
Source TransMolecular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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 Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• 131I-TM-601

Locations
Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States City of Hope Duarte California
United States Saint Louis University St. Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
TransMolecular

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Completed NCT00424554 - Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) Phase 2
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Not yet recruiting NCT00977327 - Comparison of Neuro-navigational Systems for Resection-Control of Brain Tumors N/A