Spots Global Cancer Trial Database for A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma
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Trial Identification
Brief Title: A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma
Official Title: A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma
Study ID: NCT00683761
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
St. Mary's Health Care, Grand Rapids, Michigan, United States
University of Virginia, Charlottesville, Virginia, United States
Contact Details
Name: Karen Fink, MD
Affiliation: Baylor Health Care System
Role: PRINCIPAL_INVESTIGATOR
Name: Adam Mamelak, MD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Rosenfeld, MD
Affiliation: Columbia University
Role: PRINCIPAL_INVESTIGATOR
Name: Jan Drappatz, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Patrick Wen, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Olson, MD
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR
Name: Richard Wahl, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
Name: Heather Jacene, MD
Affiliation: Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Omuro, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Edward Pan, MD
Affiliation: Moffitt Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Sean Grimm, MD
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
Name: Jeffrey Raizer, MD
Affiliation: Northwestern University
Role: PRINCIPAL_INVESTIGATOR
Name: Nimish Mobile, MD
Affiliation: University of Rochester
Role: PRINCIPAL_INVESTIGATOR
Name: Marc Chamberlain, MD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR
Name: Jay-Jiguang Zhu, MD
Affiliation: Tufts Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: John Fiveash, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
Name: David Schiff, MD
Affiliation: University of Virginia
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Edgeworth, MD
Affiliation: Vanderbilt University
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Malkin, MD
Affiliation: Medical College of Wisconsin
Role: PRINCIPAL_INVESTIGATOR
Name: Maciej Mrugala, MD
Affiliation: University of Washington
Role: PRINCIPAL_INVESTIGATOR
Name: Steven Chmura, MD
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
Name: Thomas Gribbin, MD
Affiliation: St. Mary's Health Care
Role: PRINCIPAL_INVESTIGATOR
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