Spots Global Cancer Trial Database for 131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

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Trial Identification

Brief Title: 131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

Official Title: A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma

Study ID: NCT00114309

Conditions

Malignant Glioma

Glioblastoma Multiforme

GBM

Anaplastic Astrocytoma

Oligo-Astrocytoma

Gliosarcoma

Interventions

131-I-TM-601

131I-TM601

Study Description

Brief Summary: This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.

Detailed Description: This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma. The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study. High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma. Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.