|
|
Results of a phase II trial with iodine 131-labeled murine
antitenascin monoclonal antibody 81c6 (m81c6) via surgically created resection
cavities in the treatment of patients with recurrent malignant brain tumors
David A. Reardon, G. Akabani, J. Dowell, Allan Friedman, Henry Friedman,
James Herndon, Roger McLendon, Jennifer Quinn, Jeremy Rich, James Vredenburgh,
Kara Penne, John Sampson, Timothy Shafman, Terrance Wong, R. Coleman, Michael
Zalutsky, Darell Bigner
Duke University Medical Center/The Brain Tumor
Center at Duke, Durham, NC. E-mail: REARD003@mc.duke.edu
Previously we established the maximum tolerated dose of iodine 131-labeled
murine antitenascin monoclonal antibody 81C6 (131I-81C6) injected
into the surgically created resection cavity of patients with recurrent brain
tumors to be 100 mCi.
In the current phase 2 study we have treated 40 patients
with recurrent brain tumors including 30 with glioblastoma multiforme (GBM),
five with anaplastic astrocytoma, two with anaplastic oligodendroglioma, 2 with
progressive glioma and one with metastatic adenocarcinoma.
Patients were
eligible if they underwent a gross total resection, had a Karnofsky performance
score of > 60% and had adequate bone marrow, hepatic and renal function.
The
median age was 54.5 years (range, 25-73).
Twenty-eight (70%) were male.
All
patients received prior external beam radiotherapy and 14 (35%) had also
received prior chemotherapy.
All patients received a 100 mCi dose of 131I-m81C6
except for one patient who received 67 mCi due to a small resection cavity.
Grade 3 or greater toxicity within 4 months of 131I-81C6 were
infection (n=5; 13%), hematologic (n=6; 15%) and neurologic (n=2; 5%).
Delayed
neurotoxicity (> 4 months after 131I-81C6) has not occurred in any
patient to date except for those with recurrent tumor.
No patient has required
re-operation to debulk radionecrosis.
Median follow-up for all patients is 72.4
weeks (95% CI:67,423).
Median overall survival is 59 weeks for all patients and
those with recurrent GBM, respectively.
The 1 year survival probability for all
patients and for those with GBM is 55 and 57%, respectively.
We conclude that 131I-m81C6
administered at a dose of 100 mCi is well tolerated and provides a survival
advantage for patients with recurrent malignant glioma following progression
after conventional therapy.
Copyright © 2004 American Association for Cancer Research. All rights
reserved.
Source: http://aacr04.agora.com/planner/displayabstract.asp?presentationid=6300
|
