Glioblastoma Multiforme Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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