Brain Neoplasm, Glioma
Conditions
Keywords
Brain neoplasm, Clinical trial, phase I/II
Brief summary
This drug is being developed to treat a type of brain cancer, glioma. This study was designed to determine a safe and well tolerated dose. Patients must have had prior treatment for their glioma and be eligible for removal of their recurring tumor.
Detailed description
This is an open label single-dose study to be conducted in 18 evaluable patients with recurrent high-grade glioma. Patient will undergone debulking surgery and ventricular access device placement into the tumor cavity for administration of 131I-TM-601. High-grade glioma includes glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligo-astrocytoma and gliosarcoma. The amount of 131I will remain constant. Three doses of TM-601 will be administered using a dose escalating scheme.
Interventions
DRUG131I-TM-601
Sponsors
TransMolecular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have given informed consent * Patient must have histologically confirmed supratentorial malignant glioma * Patients must have recovered from toxicity of prior therapy * Patients must be eligble for resection of the recurrent tumor
Countries
United States
Outcome results
None listed