Phase II trial of murine (131)I-labeled antitenascin monoclonal antibody 81C6 administered into surgically created resection cavities of patients with newly diagnosed malignant gliomas.
OBJECTIVE
To assess the efficacy and toxicity of intraresection cavity (131)I-labeled murine antitenascin monoclonal antibody 81C6 and determine its true response rate among patients with newly diagnosed malignant glioma.


METHODS
In this phase II trial, 120 mCi of (131)I-labeled murine 81C6 was injected directly into the surgically created resection cavity of 33 patients with previously untreated malignant glioma (glioblastoma multiforme [GBM], n = 27; anaplastic astrocytoma, n = 4; anaplastic oligodendroglioma, n = 2). Patients then received conventional external-beam radiotherapy followed by a year of alkylator-based chemotherapy.


RESULTS
Median survival for all patients and those with GBM was 86.7 and 79.4 weeks, respectively. Eleven patients remain alive at a median follow-up of 93 weeks (range, 49 to 220 weeks). Nine patients (27%) developed reversible hematologic toxicity, and histologically confirmed, treatment-related neurologic toxicity occurred in five patients (15%). One patient (3%) required reoperation for radionecrosis.


CONCLUSIONS
Median survival achieved with (131)I-labeled 81C6 exceeds that of historical controls treated with conventional radiotherapy and chemotherapy, even after accounting for established prognostic factors including age and Karnofsky performance status. The median survival achieved with (131)I-labeled 81C6 compares favorably with either (125)I interstitial brachy-therapy or stereotactic radiosurgery and is associated with a significantly lower rate of reoperation for radionecrosis. Our results confirm the efficacy of (131)I-labeled 81C6 for patients with newly diagnosed malignant glioma and suggest that a randomized phase III study is indicated.
Reardon
David A
DA
Department of Surgery, Duke University Medical Center, Durham, NC 27710, USA. reard003@mc.duke.edu
Akabani
Gamal
G
Coleman
R Edward
RE
Friedman
Allan H
AH
Friedman
Henry S
HS
Herndon
James E
JE
Cokgor
Ilkcan
I
McLendon
Roger E
RE
Pegram
Charles N
CN
Provenzale
James M
JM
Quinn
Jennifer A
JA
Rich
Jeremy N
JN
Regalado
Lorna V
LV
Sampson
John H
JH
Shafman
Timothy D
TD
Wikstrand
Carol J
CJ
Wong
Terence Z
TZ
Zhao
Xiao-Guang
XG
Zalutsky
Michael R
MR
Bigner
Darell D
DD
D000328:Adult; D000368:Aged; D000906:Antibodies / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001254:Astrocytoma / Q000628:therapy; D001932:Brain Neoplasms / Q000401:mortality / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005909:Glioblastoma / Q000628:therapy; D005910:Glioma / Q000401:mortality / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D007457:Iodine Radioisotopes; D008297:Male; D008875:Middle Aged; D009837:Oligodendroglioma / Q000628:therapy; D015996:Survival Rate; D019063:Tenascin / Q000276:immunology*; D016896:Treatment Outcome
D000906:Antibodies; D000911:Antibodies, Monoclonal; D007457:Iodine Radioisotopes; D019063:Tenascin