Publications [#132227] of James M Provenzale

Papers Published

1. DA Reardon, G Akabani, RE Coleman, AH Friedman, HS Friedman, JE Herndon 2nd, RE McLendon, CN Pegram, JM Provenzale, JA Quinn, JN Rich, JJ Vredenburgh, A Desjardins, S Gururangan, S Guruangan, M Badruddoja, JM Dowell, TZ Wong, XG Zhao, MR Zalutsky, DD Bigner, Salvage radioimmunotherapy with murine iodine-131-labeled antitenascin monoclonal antibody 81C6 for patients with recurrent primary and metastatic malignant brain tumors: phase II study results., Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 24 no. 1 (January, 2006), pp. 115-22, ISSN 1527-7755 [doi]
   (last updated on 2011/07/12)

   Abstract:
   OBJECTIVE: To assess the efficacy and toxicity of intraresection cavity iodine-131-labeled murine antitenascin monoclonal antibody 81C6 (131I-m81C6) among recurrent malignant brain tumor patients. METHODS: In this phase II trial, 100 mCi of 131I-m81C6 was injected directly into the surgically created resection cavity (SCRC) of 43 patients with recurrent malignant glioma (glioblastoma multiforme [GBM], n = 33; anaplastic astrocytoma [AA], n = 6; anaplastic oligodendroglioma [AO], n = 2; gliosarcoma [GS], n = 1; and metastatic adenocarcinoma, n = 1) followed by chemotherapy. RESULTS: With a median follow-up of 172 weeks, 63% and 59% of patients with GBM/GS and AA/AO tumors were alive at 1 year. Median overall survival for patients with GBM/GS and AA/AO tumors was 64 and 99 weeks, respectively. Ten patients (23%) developed acute hematologic toxicity. Five patients (12%) developed acute reversible neurotoxicity. One patient (2%) developed irreversible neurotoxicity. No patients required reoperation for radionecrosis. CONCLUSIONS: In this single-institution phase II study, administration of 100 mCi of 131I-m81C6 to recurrent malignant glioma patients followed by chemotherapy is associated with a median survival that is greater than that of historical controls treated with surgery plus iodine-125 brachytherapy. Furthermore, toxicity was acceptable. Administration of a fixed millicurie dose resulted in a wide range of absorbed radiation doses to the SCRC. We are now conducting a phase II trial, approved by the US Food and Drug Administration, using patient-specific 131I-m81C6 dosing, to deliver 44 Gy to the SCRC followed by standardized chemotherapy. A phase III multicenter trial with patient-specific dosing is planned.

   Keywords:
   Adult • Aged • Antibodies, Monoclonal • Biopsy • Brain Neoplasms • Female • Humans • Iodine Radioisotopes • Male • Middle Aged • Neoplasm Metastasis • Neoplasm Recurrence, Local • Radioimmunotherapy* • Salvage Therapy • Tenascin • adverse effects • immunology* • mortality • pathology • radiotherapy* • therapeutic use*