Immunotoxin Therapy in Treating Children With Recurrent Malignant Gliomas
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 recurrent childhood brain tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed grade 3 or 4 supratentorial malignant glioma by prior surgery or biopsy Anaplastic astrocytoma Glioblastoma multiforme Malignant mixed oligoastrocytoma Recurrent or progressive disease by radiology In first progression or recurrence (for patients in the phase II portion of the study only) Must have 1 solid primary lesion with a solid component measuring at least 1 cm in diameter Must have received external beam radiotherapy with tumor dose of at least 48 Gy Planning to undergo gross total resection of the tumor to remove all contrast-enhancing components of the tumor No multifocal tumor not amenable to gross tumor resection No contrast-enhancing tumor component crossing the midline No subependymal or leptomeningeal tumor dissemination No clinically significant increased intracranial pressure (e.g., impending herniation) No spinal cord compression No requirement for immediate palliative treatment PATIENT CHARACTERISTICS: Age 3 to 21 Performance status Karnofsky 60-100% (over 16 years of age) Lansky 60-100 (16 years of age and under) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 10 g/dL* Platelet count at least 100,000/mm^3* NOTE: *Transfusion independent Hepatic PT and PTT normal Renal Creatinine normal for age Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled seizures PRIOR CONCURRENT THERAPY: Biologic therapy At least 8 weeks since prior hematopoietic stem cell transplantation Chemotherapy No prior intracerebral chemotherapy for malignant glioma (except polifeprosan 20 with carmustine implant) At least 6 months since prior polifeprosan 20 with carmustine implant At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas) At least 2 weeks since prior vincristine or noncytotoxic chemotherapy No concurrent chemotherapy Endocrine therapy Concurrent steroids allowed Radiotherapy See Disease Characteristics At least 8 weeks since prior radiotherapy No prior focal radiotherapy for malignant glioma (e.g., single-fraction stereotaxic radiotherapy or brachytherapy) Prior stereotactic radiosurgery boost as part of the initial fractionated external beam radiotherapy regimen allowed Surgery See Disease Characteristics Other Recovered from prior therapy No prior investigational intracerebral agents At least 4 weeks since prior systemic investigational agents No prior localized antitumor therapy for malignant glioma No concurrent anticoagulants or antiplatelet therapy, including, but not limited to, any of the following: Heparin Fractionated heparin Warfarin Aspirin Ticlopidine Clopidogrel Dipyridamole No other concurrent investigational agents
Sites / Locations
Arms of the Study
Arm 1
Experimental
Surgery for tumor resection + IL13-PE38QQR infusion