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
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety profile/tolerability of TM-601 in this patient population, based on adverse event incidence, severity, duration, causality, seriousness and type as well as by physical examination, vital signs and clinical laboratory assessments.
Throughout the treatment phase of the study for each study patient, and for 28 days following the final study dose.
Burt Nabors, MD
University of Alabama at Birmingham
United States: Food and Drug Administration
|Wake Forest University||Winston-Salem, North Carolina 27103|
|University of Alabama||Birmingham, Alabama|
|Cedars-Sinai Medical Center||Los Angeles, California 90048|
|University of Washington||Seattle, Washington 98195|
|Columbia University||New York, New York 10032-3784|
|Northwestern University||Chicago, Illinois 60611|
|Washington University||St. Louis, Missouri 63110|