Back to resultsSafety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
Primary Purpose
Glioma, Brain Neoplasm
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
131I-TM-601
Sponsored by
About this trial
This is an interventional treatment trial for Glioma focused on measuring Brain neoplasm, Clinical trial, phase I/II
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- City of Hope
- Saint Louis University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00040573
Brief Title
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
TransMolecular
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma, Brain Neoplasm
Keywords
Brain neoplasm, Clinical trial, phase I/II
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
131I-TM-601
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana M Hablitz, MSNCRNP
Organizational Affiliation
TransMolecular
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3295
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma.
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