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
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.
Interventional
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.
Yes
Karen Fink, MD
Principal Investigator
Baylor Health Care System
United States: Food and Drug Administration
TM601-008
NCT00683761
August 2008
April 2010
Name | Location |
---|---|
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 |