TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma
Sponsored by Pediatric Brain Tumor Consortium
About this trial
Last updated 17 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 20 years ago
What is this trial about?
What are the Participation Requirements?
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
