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Results
of a Phase II Trial in the Treatment of Recurrent Patients with Brain Tumors
Treated with Iodine 131 Anti-Tenascin Monoclonal Antibody 81C6 Via Surgically
Created Resection Cavities
I.
Cokgor, G. Akabani, A. Friedman, R. Coleman, M. Zalutsky, R. McLendon, S.
Bigner, Z. Xiao-Guang, C. Pegram, C. Wikstrand, J. Herndon, J. Provenzale, H.
Friedman, D. Bigner
We
have conducted a phase II trial of Iodine-131 radiolabeled 81C6 monoclonal
antibody (MAb) administered via surgically created resection cavities in
thirty-one patients with recurrent malignant brain tumors who have seen previous
external beam radiation and/or chemotherapies.
Previously we have shown that the maximum tolerated dose was reached at 100
mCi.
Twenty-nine of these patients were treated with murine 81C6 monoclonal antibody
and two of them were treated with chimeric 81C6.
Twenty-three of the patients had glioblastoma multiforme; one had gliosarcoma;
three had anaplastic astrocytoma and one had metastatic adenocarcinoma to the
brain.
We followed the patients for response until death.
Determination of tumor response was based on the combination of MRI scans, 18FDG
PET scans, and clinical examination. Thirty patients were analyzed for dosimetry
purposes.
The average absorbed dose (range) to the 2-cm cavity interface was 38 (17–110)
Gy.
Median survival is found to be 58.7 weeks in the Kaplan Meier Survival
curve.
As of November 1999, thirteen patients are alive.
Only one of the patients had major hematological toxicity.
Iodine 131 radiolabeled 81C6 monoclonal antibody therapy has shown promising
results therefore we will pursue with the phase III trial for the efficacy of
the treatment compared to the standard therapy of care.
©
Copyright 2002 American Society of Clinical Oncology. All rights reserved
worldwide.
Source:
http://www.asco.org/asco/ascoMainConstructor/1,1003,_12-002324-00_29-00A-00_18-002000-00_19-00137,00.asp |