Karen[a]
Phase II trial of iodine 131-labeled murine anti-tenascin monoclonal anti-body 81C6 (M81C6) via surgically created resection cavity in the treatment of patients with recurrent malignant brain tumors.
Abstract No: 1569
Author(s): M. A. Badruddoja, D. A. Reardon, G. Akabani, A. H. Friedman, H. S. Friedman, J. N. Rich, J. A. Quinn, K. Penne, J. J. Vredenburgh, D. D. Bigner; Duke Medical Center, Durham, NC
Background:
In a prior phase I study we established the dose of 100mCi as the maximum tolerated dose of iodine 131-labeled murine anti-tenascin antibody 81C6 (131I-81C6) injected into a surgically created resection cavity (SCRC) for the treatment of recurrent malignant glioma in adult patients. Methods: In the current phase II study we have treated 42 patients with recurrent brain tumors (GBM=32, AA=6, AO=2, infiltrating glioma = 1 , metastatic =1). Patients were included into study if they had: 1) gross total resection, 2) KPS > 60%, 3) normal bone marrow and normal hepatic and renal function. All patients had received standard external beam radiation and 14 (33%) patients had received prior chemotherapy.
Results:
The median age was 54.5 years and 27 patients (64%) were males. All patients received 100mCi except for two patients that received 67mCi and 75mCi respectively due to the limited size of the SCRC. Toxicities were divided into acute (< 4 weeks), subacute (4-16 weeks) and delayed (>16 weeks) periods. Acute and sub-acute reversible, grade 4 hematologic toxicity was seen in 2 patients (4%) and 3 (7%) patients, respectively. Delayed grade 3 or 4 neurotoxicity was seen in 2 patients (4%). The median survival of all patients and GBM patients was 59 weeks for both groups, respectively. For patients with GBM the probability of 1-year survival is 0.56 (CI-95%; 0.41-0.78). As of December 16, 2003, 15 patients remain alive with a median follow up of 81.9 weeks for GBMs and 78.9 weeks for all patients.
Conclusions;
I131- labeled murine anti-tenascin antibody 81C6 is associated with minimal hematologic toxicity and provides an improvement in survival in patients with recurrent malignant glioma that have failed conventional therapy.
Event: 2004 ASCO Annual Meeting
Presenter: Michael A. Badruddoja, MD
Session: Central Nervous System Tumors