A Phase 2a, Multi-Center, Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma
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