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Iodine-131-labeled
antitenascin monoclonal antibody 81C6 treatment of patients with recurrent
malignant gliomas: phase I trial results
Bigner DD, Brown MT, Friedman AH, Coleman RE, Akabani G, Friedman HS,
Thorstad WL, McLendon RE, Bigner SH, Zhao XG, Pegram CN, Wikstrand CJ, Herndon
JE 2nd, Vick NA, Paleologos N, Cokgor I, Provenzale JM, Zalutsky MR
Department of Pathology, Duke University Medical Center, Durham,
NC 27710, USA. bigne001@mc.duke.edu
Purpose. To determine the maximum-tolerated dose (MTD) of iodine 131
(131I)-labeled 81C6 monoclonal antibody (mAb) in brain tumor patients with
surgically created resection cavities (SCRCs) and to identify any objective
responses to this treatment.
Methods.
In this phase I trial, eligible patients were treated with a single injection of
131I-labeled 81C6.
Cohorts of three to six patients were treated with escalating dosages of 131I
(starting dose of 20 mCi with a 20-mCi escalation in subsequent cohorts)
administered through an Ommaya reservoir in the SCRC.
Patients were followed up for toxicity and response until death or for a minimum
of 1 year after treatment.
The SCRC patients, who were previously irradiated, were followed up without
additional treatment unless progressive disease was identified.
Results.
We administered 36 treatments of 131I doses up to 120 mCi to 34 previously
irradiated patients with recurrent or metastatic brain tumors.
Dose-limiting toxicity was reached at 120 mCi and was limited to neurologic or
hematologic toxicity.
None of the patients treated with less than 120 mCi developed significant
neurologic toxicity; one patient developed major hematologic toxicity
(MHT).
The estimated median survival for patients with glioblastoma multiforme (GBM)
and for all patients was 56 and 60 weeks, respectively.
Conclusion.
The MTD for administration of 131I-labeled 81C6 into the SCRCs of previously
irradiated patients with recurrent primary or metastatic brain tumors was 100
mCi.
The dose-limiting toxicity was neurologic toxicity.
We are encouraged by the minimal toxicity and survival in this phase I
trial.
Radiolabeled mAbs may improve the current therapy for brain tumor patients.
PMID:
9626222 [PubMed - indexed for MEDLINE]
Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9626222&dopt=Abstract |
