Publications [#132185] of James M Provenzale

Papers Published

1. DD Bigner, MT Brown, AH Friedman, RE Coleman, G Akabani, HS Friedman, WL Thorstad, RE McLendon, SH Bigner, XG Zhao, CN Pegram, CJ Wikstrand, JE Herndon, NA Vick, N Paleologos, I Cokgor, JM Provenzale, MR Zalutsky, Iodine-131-labeled antitenascin monoclonal antibody 81C6 treatment of patients with recurrent malignant gliomas: phase I trial results., Journal of clinical oncology : official journal of the American Society of Clinical Oncology, UNITED STATES, vol. 16 no. 6 (June, 1998), pp. 2202-12, ISSN 0732-183X
   (last updated on 2007/02/06)

   Abstract:
   PURPOSE: To determine the maximum-tolerated dose (MTD) of iodine 131 (131I)-labeled 81C6 monoclonal antibody (mAb) in brain tumor patients with surgically created resection cavities (SCRCs) and to identify any objective responses to this treatment. METHODS: In this phase I trial, eligible patients were treated with a single injection of 131I-labeled 81C6. Cohorts of three to six patients were treated with escalating dosages of 131I (starting dose of 20 mCi with a 20-mCi escalation in subsequent cohorts) administered through an Ommaya reservoir in the SCRC. Patients were followed up for toxicity and response until death or for a minimum of 1 year after treatment. The SCRC patients, who were previously irradiated, were followed up without additional treatment unless progressive disease was identified. RESULTS: We administered 36 treatments of 131I doses up to 120 mCi to 34 previously irradiated patients with recurrent or metastatic brain tumors. Dose-limiting toxicity was reached at 120 mCi and was limited to neurologic or hematologic toxicity. None of the patients treated with less than 120 mCi developed significant neurologic toxicity; one patient developed major hematologic toxicity (MHT). The estimated median survival for patients with glioblastoma multiforme (GBM) and for all patients was 56 and 60 weeks, respectively. CONCLUSION: The MTD for administration of 131I-labeled 81C6 into the SCRCs of previously irradiated patients with recurrent primary or metastatic brain tumors was 100 mCi. The dose-limiting toxicity was neurologic toxicity. We are encouraged by the minimal toxicity and survival in this phase I trial. Radiolabeled mAbs may improve the current therapy for brain tumor patients.

   Keywords:
   Adolescent • Adult • Antibodies, Monoclonal • Biopsy • Brain Neoplasms • Child • Female • Glioma • Humans • Immunoassay • Immunotherapy • Injections, Intralesional • Iodine Radioisotopes • Magnetic Resonance Imaging • Male • Middle Aged • Neoplasm Recurrence, Local • Nervous System Diseases • Survival Rate • Tenascin • Tomography, Emission-Computed • Treatment Outcome • administration & dosage • adverse effects • chemically induced • immunology • immunology* • mortality • pathology • therapeutic use* • therapy • therapy*