A Phase I/II Open Label, Single Dose Study of Intracavitary Administered 131I-TM-601 in Adult Patients With Recurrent High-Grade Glioma.

TransMolecular6 sites in 1 country18 target enrollmentStarted: June 1, 2002Last updated: March 31, 2009

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor
Enrollment: 18
Locations: 6

Study Overview Study Design Eligibility Criteria Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion 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

Exclusion Criteria

Not provided

Investigators

Sponsor

TransMolecular

Sponsor Class

Industry

Study Sites (6)

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