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

TransMolecular

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glioma; Brain Neoplasm

Treatments: Drug: 131I-TM-601

Study type: Interventional

Funder types: Industry

Identifiers

NCT00040573

TM601-001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)