Prior treatment with Iodine-131 in the past five years
Blood transfusions within 60 days of study start
Hematopoietic growth factor therapy within 60 days of study start
Prior stem cell transplantation
Clinically evident ascites or with peritoneal carcinomatosis
Clinically significant cardiac co-morbidities including: CHF, a LVEF< 40%, unstable angina pectoris, serious cardiac arrhythmia requiring medication or a pacemaker, myocardial infarction within the past six months
Clinically significant pulmonary impairment defined as an SaO2 on room air of 93% or less
Concurrent or recent use of thrombolytic agents, or full-dose anticoagulants
Uncontrolled hypertension or patients with uncontrolled diabetes
Grade II-IV peripheral vascular disease or peripheral vascular surgery within the past year
Less than 4 weeks since prior major surgery
Known positive for HIV, Hepatitis C (active, previously treated or both), or is Hepatitis B core antigen positive
Concurrent chronic use of aspirin (325 mg/day or more)
Pregnant or lactating
Patients with colostomy/ileostomy
Poor venous access
Prior allergic reactions to iodine, or other study agents
Significant traumatic injury within the past 4 weeks
Ongoing or active infection requiring antibiotics or with a fever >38.1°C (>101° F) within 3 days of the first scheduled day of dosing
Patients who are hospitalized
All locations for NCT00925275
United States (4)
City of Hope
Duarte, California, United States, 91010
Georgetown University, Lombardi Cancer Center
Washington, District of Columbia, United States, 20007
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Duke University Medical Center
Durham, North Carolina, United States, 27710
View full eligibility
Tris trial is registered with FDA with number: NCT00925275. The sponsor of the trial is Cellectar, Inc and it is looking for 9 volunteers for the current phase.
Official trial title: A Phase I, Multi-Center, Open-Label, Dosimetry Study of I-131-CLR1404 in Patients With Relapsed or Refractory Advanced Solid Tumors Who Have Failed Standard Therapy or for Whom No Standard Therapy Exists
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