Clinical Trial Finder

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

OBJECTIVES: Primary.

• - Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme.

Secondary.

• - Determine the biodistribution and radiation dosimetry of this drug in these patients.

• - Determine the toxicity and tolerability of this drug in these patients.

• - Determine the overall survival, median time of survival, and 6-month survival of patients treated with this drug.

OUTLINE: This is an open-label, multicenter, dose-escalation study of therapeutic doses of iodine I 131 monoclonal antibody TNT-1/B (^131I MOAB TNT-1/B). The first 12 patients accrued to the study undergo stereotactic placement of 2 catheters within the contrast-enhancing tumor on day 0. These patients then receive an imaging dose of ^131I MOAB TNT-1/B interstitially over approximately 25 hours on day 1 followed by dosimetry, biodistribution evaluations, and whole body imaging over an 8-10 day period. Beginning at least 2 weeks, but no more than 4 weeks later, all patients undergo catheter placement as above. One day later, patients receive a therapeutic dose of ^131I MOAB TNT-1/B interstitially over approximately 25 hours. Cohorts of 3-6 patients receive escalating therapeutic doses of ^131I MOAB TNT-1/B until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients are treated at the MTD. After completion of study treatment, patients are followed weekly for 3 weeks, at 6 weeks, at 4, 8, and 12 weeks (for the first 12 patients accrued to the study), every 4 weeks until disease progression, and then every 8 weeks thereafter. PROJECTED ACCRUAL: Approximately 22 patients will be accrued for this study.