131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
Malignant Glioma, Glioblastoma Multiforme, GBM
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring High grade recurrent glioma, Phase II, Multi-Center, Open label, Multiple dose, Brain Cancer, Brain Tumor, GBM, glioma
Eligibility Criteria
Inclusion Criteria: Patient must have a histologically confirmed unilateral, supratentorial malignant glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or malignant oligoastrocytoma) Patient must have glioma progression or recurrence following radiotherapy that was no less than 50 Gy (+/- chemotherapy; +/- surgery) Patient must be a candidate for resection of the recurrent tumor (surgical requirements are detailed in the study protocol) Imaging must show recurrent, unilateral, supratentorial tumor(s) There is no diffuse leptomeningeal disease For patients with previous radiosurgery or enhanced radiotherapy, based on neurosurgeon's judgment, the area of enhancement can be removed during the surgery Patient must have recovered from toxicity of prior therapy Patient must be > 18 years of age. Patient has a Karnofsky Performance Status greater than or equal to 60% Patient must have a life expectancy of at least 3 months Patient has no uncontrolled seizures or other neurological conditions which would interfere with evaluation Patient is not currently receiving, or is not anticipated to receive, concomitant anticancer agent(s) during the course of this study Patient must have given informed consent Exclusion Criteria: Patient with concurrent malignancy (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with prior malignancies that have not been disease-free for five years Patient has presence of non-contiguous satellite lesions Patient with known allergy to iodine, iodine containing drugs or contrast agent Patient with the potential for pregnancy or impregnating their partner and who do not agree to follow an acceptable birth control method to avoid conception Pregnant or breast feeding females Patient is not maintained on a stable corticosteroid regimen New onset of conditions not present prior to surgery (as detailed in Study Protocol) which would make patient an inappropriate study candidate, or as determined by Investigator
Sites / Locations
- University of Alabama at Birmingham
- City of Hope
- Cedars-Sinai Medical Center
- Florida Hospital Cancer Institute
- Moffitt Cancer Center
- Emory University
- Northwestern University
- University of Chicago
- Johns Hopkins Medical Center
- Tufts-New England Medical Center
- Henry Ford Hospital
- Lacks Cancer Center at St. Mary's Health Care
- St. Louis Hospital
- Washington University Medical Center
- Columbia University Medical Center
- Carolina Neurosurgery and Spine
- Mary Crowley Medical Research Center
- Huntsman Cancer Institute
- University of Washington
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
3 Dose Regimen
6 Dose Regimen