Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma

This is an interventional treatment trial for Glioma Read More

Inclusion Criteria:

• Histologically confirmed high-grade glioblastoma multiforme (GBM)
• Failed prior therapy with Avastin
• Radiologic evidence of tumor progression
• Received at least 45 Gy and no more than 66 Gy prior radiotherapy
• Ambulatory with an ECOG performance status of 0 to 2 (Appendix C)
• 18 years of age or older

Exclusion Criteria:

• Received more than 25% of total bone marrow irradiated, total body or hemi-body irradiation or prior radioisotope therapy (except for benign thyroid disease)
• Prior radiation therapy or chemotherapy within 4 weeks of start of study
• Another active medical condition(s) or organ disease(s) that may compromise subject safety or interfere with safety and/or outcome evaluation of study drug
• Laboratory abnormalities, including but not limited to: WBC < 3000/uL, Absolute neutrophil count < 1500/uL, Platelets < 150,000/uL, Hemoglobin ≤ 9.0 gm/dL, Total bilirubin > 1.5 x upper limit of normal for age, SGOT or SGPT > 3 x upper limit of normal for age if no liver metastases or > 5 x upper limit of normal for age in the presence of liver metastases, Serum creatinine > 1.5 x upper limit of normal for age, 2+ proteinuria or casts indicative of intrinsic renal disease
• Treatment with investigational drug, investigational biologic, or investigational therapeutic device within 28 days of initiating study treatment
• Received prior stem cell transplantation
• Clinically significant cardiac co-morbidities including congestive heart failure (New York Heart Association class III-IV heart disease), left ventricular ejection fraction < 40%, unstable angina pectoris, serious cardiac arrhythmia requiring medication or pacemaker, myocardial infarction within past 6 months
• Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters).
• Uncontrolled hypertension as defined by systolic blood pressure > 150 mm/Hg, diastolic blood pressure > 100 mm/Hg or uncontrolled diabetes that would compromise subject safety or interfere with safety and/or outcome evaluation of study drug
• Major surgery within 4 weeks of enrollment
• Poor venous access and unable to receive study drug into a peripheral venous catheter
• Significant traumatic injury within past 4 weeks
• Ongoing or active infection requiring antibiotics or with fever >38.1º C (>101º F) within 3 days of first scheduled day of dosing
• Receiving concurrent hemodialysis or peritoneal dialysis
• Known positive for HIV, Hepatitis C (active, previously treated or both), or is Hepatitis B core antigen positive
• Pregnant or lactating
• Hospitalized