I trial results of iodine-131-labeled antitenascin monoclonal antibody 81C6
treatment of patients with newly diagnosed malignant gliomas
Cokgor I, Akabani G, Kuan CT, Friedman HS, Friedman AH, Coleman RE, McLendon
RE, Bigner SH, Zhao XG, Garcia-Turner AM, Pegram CN, Wikstrand CJ, Shafman TD,
Herndon JE 2nd, Provenzale JM, Zalutsky MR, Bigner DD
Department of Pathology, Duke University Medical Center, Durham,
NC 27710, USA. firstname.lastname@example.org
Purpose. To determine the maximum-tolerated dose (MTD) of iodine-131
((131)I)-labeled 81C6 antitenascin monoclonal antibody (mAb) administered
clinically into surgically created resection cavities (SCRCs) in malignant
glioma patients and to identify any objective responses with this
and Methods. In
this phase I trial, newly diagnosed patients with malignant gliomas with no
prior external-beam therapy or chemotherapy were treated with a single injection
of (131)I-labeled 81C6 through a Rickham reservoir into the resection
The initial dose was 20 mCi and escalation was in 20-mCi increments.
Patients were observed for toxicity and response until death or for a minimum of
1 year after treatment.
We treated 42 patients with (131)I-labeled 81C6 mAb in administered doses up to
Dose-limiting toxicity was observed at doses greater than 120 mCi and consisted
of delayed neurotoxicity.
None of the patients developed major hematologic toxicity.
Median survival for patients with glioblastoma multiforme and for all patients
was 69 and 79 weeks, respectively.
The MTD for administration of (131)I-labeled 81C6 into the SCRC of newly
diagnosed patients with no prior radiation therapy or chemotherapy was 120
Dose-limiting toxicity was delayed neurologic toxicity.
We are encouraged by the survival and toxicity and by the low 2.5% prevalence of
debulking surgery for symptomatic radiation necrosis.
11078500 [PubMed - indexed for MEDLINE]