A Phase I Imaging and Safety Study of Intravenous 131-I-TM-601 Labeled Chlorotoxin in Patients With Recurrent or Refractory Somatic and/or Cerebral Metastatic Solid Tumors
Sponsor study identifier
interventional
60
1 country
6
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
August 2008
Actual (reported)This study is designed to evaluate the ability of intravenously (IV)administered 131-I-labeled TM-601 (chlorotoxin) to provide tumor-specific localization(via radiographic imaging) in patients with recurrent or refractory primary solid tumors with evidence of metastatic involvement. (Refractory tumors are non-responsive to standard treatment.) The safety and tolerability of IV administered 131-I-TM-601 in this patient population will be evaluated as part of this study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 18, 2006
Actual (reported)September 21, 2006
Actual (reported)July 2008
Actual (reported)August 2008
Actual (reported)To evaluate whether intravenous (IV) 131-I-TM-601 provides tumor-specific localization in patients with recurrent or refractory metastatic (including brain metastases) solid tumors
between 1 - 72 hours post study dose
To determine the distribution and dosimetry of intravenously administered 131-I-TM-601
between 1 - 72 hours post study dose
To determine the safety and tolerability of IV administered 131-I-TM-601.
within 28 days of last study drug administration
Patients will be administered 1 - 3 (Test Doses A, B, and Dose C) escalating doses of 131I-TM601 by intravenous (IV) administration. Each dose will be administered as a single administration, scheduled at one-week intervals. Test Dose A - 10 mCi (+/- 20%)/0.2 mg TM601 (131I-TM601) Test Dose B - 20 mCi (+/- 20%)/0.4 mg TM601 (131I-TM601) Dose C - 30 mCi (+/- 10%)/0.6 mg TM601 (131I-TM601)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Northwestern University, The Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111, United States
Lacks Cancer Center at St. Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75201, United States
Mamelak AN, Jacoby DB. Targeted delivery of antitumoral therapy to glioma and other malignancies with synthetic chlorotoxin (TM-601). Expert Opin Drug Deliv. 2007 Mar;4(2):175-86. doi: 10.1517/17425247.4.2.175.
Mamelak AN, Rosenfeld S, Bucholz R, Raubitschek A, Nabors LB, Fiveash JB, Shen S, Khazaeli MB, Colcher D, Liu A, Osman M, Guthrie B, Schade-Bijur S, Hablitz DM, Alvarez VL, Gonda MA. Phase I single-dose study of intracavitary-administered iodine-131-TM-601 in adults with recurrent high-grade glioma. J Clin Oncol. 2006 Aug 1;24(22):3644-50. doi: 10.1200/JCO.2005.05.4569.
John Fiveash, MD
University of Alabama at Birmingham
Jeffrey Raizer, M.D.
Northwestern University
Neil Senzer, MD
Mary Crowley Medical Research Center
Thomas Gribbins, MD
Lacks Cancer Center at St. Mary's Health Care
First Submitted
September 18, 2006
First Posted
September 21, 2006
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Contact the study team to confirm eligibility.
Hockaday DC, Shen S, Fiveash J, Raubitschek A, Colcher D, Liu A, Alvarez V, Mamelak AN. Imaging glioma extent with 131I-TM-601. J Nucl Med. 2005 Apr;46(4):580-6.
Lyons SA, O'Neal J, Sontheimer H. Chlorotoxin, a scorpion-derived peptide, specifically binds to gliomas and tumors of neuroectodermal origin. Glia. 2002 Aug;39(2):162-73. doi: 10.1002/glia.10083.
Jay-Jiguang Zhu, MD
Tufts Medical Center
Steven Chmura, MD
University of Chicago
Study Completion
August 2008
Actual (reported)Last Updated
March 31, 2009
Record last verified: 2009-03
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