Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult gliosarcoma, adult giant cell glioblastoma, recurrent adult brain tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme Focal disease Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed Gross tumor volume 5-60 mL No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles No bilateral non-contiguous gadolinium-enhancing tumor No diffuse disease, defined as any satellite lesion > 1.5 cm from the anticipated location of a catheter tip OR > 2 satellite lesions No ventricular invasion outside the anticipated radiotherapy volume PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL Hepatic Bilirubin ≤ 1.5 mg/dL AST and ALT ≤ 2.5 times upper limit of normal (ULN) Hepatitis B negative No evidence of active hepatitis Renal Creatinine ≤ 1.7 mg/dL BUN ≤ 2 times ULN Cardiovascular No uncontrolled hypertension No unstable angina pectoris No uncontrolled cardiac dysrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Able to undergo MRI Mini Mental State Exam score ≥ 15 No serious infection No other medical illness that would preclude study participation No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance No known or suspected allergy to study drug or iodine No known HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy No prior monoclonal antibodies No prior local immunotherapy or treatment with the following biologic agents: Immunotoxins Immunoconjugates Antiangiogenesis compounds Antisense agents Peptide receptor antagonist Interferons Interleukins Tumor infiltrating lymphocytes Lymphokine-activated killer cells Gene therapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer^® ) Endocrine therapy Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entry Radiotherapy See Disease Characteristics At least 3 months since prior radiotherapy No prior brachytherapy or radiosurgery Surgery At least 4 weeks since prior surgery Other Recovered from all prior therapy At least 1 month since prior investigational agents No more than 2 prior treatment regimens No other prior local therapy
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
- Winship Cancer Institute of Emory University
- Wake Forest University Comprehensive Cancer Center
- Abramson Cancer Center of the University of Pennsylvania