Glioblastoma Multiforme Clinical Trial
Official title:
A Phase I Dose Escalation Study Evaluating the Safety and Biologically Active Dose of TM-601 Based on Perfusion MRI Imaging Criteria in Patients With Progressive and/or Recurrent Malignant Glioma
The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in adult patients with recurrent malignant glioma.
This Phase I study will evaluate the safety of TM-601 in patients with recurrent malignant
glioma who have failed first-line, standard therapy.
Study patients will be assigned to receive treatment in 1 of 6 treatment cohorts. Patients
will be assigned to each dose level in groups of 3-6 (depending upon treatment response seen
within each cohort), with escalation to the next highest dose dependent upon demonstrated
tolerance in the previous dosing group.
Patients will be administered an imaging dose of 131I-TM-601, intravenously, to demonstrate
tumor-specific localization prior to study treatment with non-labeled TM-601. Eligible
patients demonstrating tumor-specific imaging will be assigned to a treatment cohort and
will received non-labeled TM-601 once a week for 3 weeks, followed by clinical follow-up
visits and MR imaging.
Data from this study will help determine the IV dose of TM-601 required to produce MR
perfusion changes (as well as other biomarker changes) in patients with recurrent malignant
glioma. It is not known whether participation in this trial will provide patients with
benefit in terms of improved tumor control, although pre-clinical evidence and evidence from
other clinical trials with 131I TM-601 suggest that TM-601 is an active agent in malignant
glioma.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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