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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

CDR0000344416

Status

Terminated

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

3 to 21 Years
All Sexes

Trial Timing

Ended 20 years ago

What is this trial about?

RATIONALE: The TP-38 toxin can locate tumor cells and kill them without harming normal cells. Giving TP-38 toxin directly into the tumor may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of TP-38 toxin administered directly into the brain and to see how well it works in treating young patients with recurrent or progressive supratentorial high-grade glioma.

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