Glioblastoma Multiforme Clinical Trial
Official title:
A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma
The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.
This is a multi-center, open label, non-randomized, Phase 1/2 study evaluating the use of
multiple intravenous doses of 131I-TM601 in patients with progressive and/or recurrent
malignant glioma.
The study will be conducted in two phases. Prior to initiating treatment as part of this
study, patients will be administered a single imaging dose of 131I-TM601, IV, to demonstrate
tumor uptake. Only patients demonstrating tumor uptake will remain on the study. During the
first, Dose Escalation Phase of the study, eligible patients will be assigned in groups of
3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between 2-5
weekly IV doses of 131I-TM601, with escalation to the next highest dose dependent upon
demonstrated tolerance in the previous dosing group. Patients enrolled in the second phase
will be assigned to a dose determined by the experience in the first phase.
Patients in both study phases will have safety parameters evaluated continuously throughout
the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28 days
following the final study dose, and then at quarterly intervals scheduled at 3 month
intervals following the first study dose, until disease progression.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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