TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
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 childhood high-grade cerebral astrocytoma, recurrent childhood cerebral astrocytoma, childhood oligodendroglioma, childhood supratentorial ependymoma, recurrent childhood ependymoma, recurrent childhood brain tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial malignant glioma Recurrent or progressive disease Amenable to gross total resection, clinically indicated partial resection, or biopsy Tumor must have a single solid portion at least 1 cm and no greater than 5 cm in maximum diameter No tumor crossing midline Tumors invading the corpus callosum that do not extend beyond to midline or into the contralateral hemisphere allowed No more than 1 focus of tumor No tumors involving the brainstem or cerebellum No tumor dissemination (i.e., subependymal or leptomeningeal) Must be on steroids ≥ 3 days prior to surgery Must have received prior external beam radiotherapy (tumor dose at least 45 Gy) and completed therapy at least 8 weeks before study entry No impending herniation, including midline shift greater than 0.5 cm No requirement for immediate palliative treatment PATIENT CHARACTERISTICS: Age 3 to 21 Performance status Karnofsky 60-100% (patients over 16 years of age) OR Lansky 60-100% (patients age 16 and under) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3* Hemoglobin at least 9 g/dL* NOTE: *Transfusion independent Hepatic ALT and AST less than 2.5 times upper limit of normal (ULN) PT and PTT no greater than ULN Renal Creatinine less than 1.5 times normal OR Glomerular filtration rate greater than 70 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 30 days after study participation No uncontrolled seizures No active infection requiring treatment No unexplained febrile illness No known or suspected allergies to local anesthetics No systemic disease or other condition that may be associated with unacceptable anesthetic/operative risk and/or that would preclude study completion No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy At least 8 weeks since prior hematopoietic stem cell transplantation Chemotherapy At least 6 months since prior polifeprosan 20 with carmustine implant (Gliadel® wafer) At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas and 2 weeks for vincristine) At least 2 weeks since prior non-cytotoxic chemotherapy No other prior intracerebral chemotherapy No concurrent chemotherapy Endocrine therapy Concurrent steroids allowed Radiotherapy See Disease Characteristics No prior focal radiotherapy (e.g., gamma knife radiosurgery, stereotactic radiosurgery, or brachytherapy) No concurrent radiotherapy Surgery Not specified Other Recovered from prior therapy At least 4 weeks since prior anticancer investigational agents No prior localized antitumor therapy for malignant glioma No other concurrent investigational agent No other concurrent anticancer (including alternative anticancer medicines/treatment) agent or therapy
Sites / Locations
- Children's National Medical Center
- Children's Memorial Hospital - Chicago
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Duke Comprehensive Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Children's Hospital of Pittsburgh
- St. Jude Children's Research Hospital
- Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital