Spots Global Cancer Trial Database for Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma
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Trial Identification
Brief Title: Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma
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
Study ID: NCT00591058
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in adult patients with recurrent malignant glioma.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
Northwestern University, Chicago, Illinois, United States
Washington University, St. Louis, Missouri, United States
Columbia University, New York, New York, United States
Wake Forest University, Winston-Salem, North Carolina, United States
University of Washington, Seattle, Washington, United States
Contact Details
Name: Burt Nabors, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
Name: Glenn Lesser, MD
Affiliation: Wake Forest University
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Rosenfeld, MD, PhD
Affiliation: Columbia University
Role: PRINCIPAL_INVESTIGATOR
Name: Sean Grimm, MD
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
Name: Maceij Mrugala, MD
Affiliation: University of Washington at Seattle
Role: PRINCIPAL_INVESTIGATOR
Name: Jeremy Rudnick, MD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Gerry Linette, MD
Affiliation: Washington University at St. Louis
Role: PRINCIPAL_INVESTIGATOR
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