A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma
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
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
The safety and tolerability of multiple doses of intravenously (IV) administered 131I-TM601 in adult patients with progressive and/or recurrent malignant glioma with measurable disease.
Safety will be evaluated throughout the treatment and follow-up phase for all study patients; dose escalation decisions will be based on safety experience for each patient at 21 days following the final treament dose.
Karen Fink, MD
Baylor Health Care System
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|University of Virginia||Charlottesville, Virginia 22908|
|University of Chicago||Chicago, Illinois 60637|
|St. Mary's Health Care||Grand Rapids, Michigan 49503|