Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 1510
© 2005 American Society of Clinical Oncology

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Abstract

Results of a phase II study of 131 Iodine-labeled anti-tenascin murine monoclonal antibody 81C6 (m81C6) administered to deliver a targeted radiation boost dose of 44 Gy to the surgically created cystic resection cavity perimeter in the treatment of patients with newly diagnosed primary and metastatic brain tumors

Duke Univ Medcl Ctr, Durham, NC

1510

Prior trials using a "fixed" dose of ¹³¹I anti-tenascin monoclonal antibody 81C6 (¹³¹I-81C6) administered into the surgically created resection cavity (SCRC) of patients with either newly diagnosed or recurrent malignant glioma have shown encouraging survival and acceptable toxicity. Dosimetry analyses from these studies predict that the delivery of a "targeted"44 Gy boost to the SCRC by ¹³¹I-81C6 may lower toxicity and possibly improve outcome compared to the "fixed" dose regimen. The current study was designed to evaluate the efficacy and toxicity of administering a dose of ¹³¹I-81C6 to achieve a "targeted" 44Gy boost to the SCRC perimeter. Eligibility criteria: adults with newly diagnosed and previously untreated MG; gross total resection; lack of communication between the SCRC and the CSF space; KPS > 60%; and adequate bone marrow, kidney and hepatic function. A pretreatment dosimetry study with approximately 0.5mCi of ¹³¹I-81C6 is performed to determine the therapeutic dose of ¹³¹I-81C6 required to achieve the 44Gy "targeted" boost in each individual patient. Following the therapeutic dose of ¹³¹I-81C6 all patients undergo conventional XRT and systemic chemotherapy. 21 patients have been treated to date including 15 with GBM and 6 with AA/AO. The median age was 49 years (24–70) and 76% were male. The median dose of ¹³¹I-81C6 administered was 62mCi (25–150). 20 patients have successfully achieved a 44Gy (+/–10%) boost to the SCRC perimeter. Toxicity has been limited to grade 3 reversible hematologic toxicity in 15%. No episodes of grade 4 toxicity have occurred. With a median follow-up of 62.7 weeks, the median survival for patients with newly diagnosed GBM is 93.9 weeks and the median survival for the AA/AO patients has not been achieved. The administration of this 131-I-81C6 to achieve a 44Gy "targeted" boost is feasible and associated with encouraging survival and low toxicity indicating that this approach deserves further evaluation.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting