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Phase II trial of iodine 131-labeled murine anti-tenascin monoclonal anti-body 81C6 (M81C6) via surgically created resection cavity in the treatment of patients with recurrent malignant brain tumors.

Publication ,  Journal Article
Badruddoja, MA; Reardon, DA; Akabani, G; Friedman, AH; Friedman, HS; Rich, JN; Quinn, JA; Penne, K; Vredenburgh, JJ; Bigner, DD
Published in: J Clin Oncol
July 15, 2004

1569 Background: In a prior phase I study we established the dose of 100mCi as the maximum tolerated dose of iodine 131-labeled murine anti-tenascin antibody 81C6 (131I-81C6) injected into a surgically created resection cavity (SCRC) for the treatment of recurrent malignant glioma in adult patients. METHODS: In the current phase II study we have treated 42 patients with recurrent brain tumors (GBM=32, AA=6, AO=2, infiltrating glioma = 1, metastatic =1). Patients were included into study if they had: 1) gross total resection, 2) KPS > 60%, 3) normal bone marrow and normal hepatic and renal function. All patients had received standard external beam radiation and 14 (33%) patients had received prior chemotherapy. RESULTS: The median age was 54.5 years and 27 patients (64%) were males. All patients received 100mCi except for two patients that received 67mCi and 75mCi respectively due to the limited size of the SCRC. Toxicities were divided into acute (< 4 weeks), subacute (4-16 weeks) and delayed (>16 weeks) periods. Acute and sub-acute reversible, grade 4 hematologic toxicity was seen in 2 patients (4%) and 3 (7%) patients, respectively. Delayed grade 3 or 4 neurotoxicity was seen in 2 patients (4%). The median survival of all patients and GBM patients was 59 weeks for both groups, respectively. For patients with GBM the probability of 1-year survival is 0.56 (CI-95%; 0.41-0.78). As of December 16, 2003, 15 patients remain alive with a median follow up of 81.9 weeks for GBMs and 78.9 weeks for all patients. CONCLUSIONS: I(131)- labeled murine anti-tenascin antibody 81C6 is associated with minimal hematologic toxicity and provides an improvement in survival in patients with recurrent malignant glioma that have failed conventional therapy. No significant financial relationships to disclose.

Duke Scholars

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

July 15, 2004

Volume

22

Issue

14_suppl

Start / End Page

1569

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
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Badruddoja, M. A., Reardon, D. A., Akabani, G., Friedman, A. H., Friedman, H. S., Rich, J. N., … Bigner, D. D. (2004). Phase II trial of iodine 131-labeled murine anti-tenascin monoclonal anti-body 81C6 (M81C6) via surgically created resection cavity in the treatment of patients with recurrent malignant brain tumors. J Clin Oncol, 22(14_suppl), 1569.
Badruddoja, M. A., D. A. Reardon, G. Akabani, A. H. Friedman, H. S. Friedman, J. N. Rich, J. A. Quinn, K. Penne, J. J. Vredenburgh, and D. D. Bigner. “Phase II trial of iodine 131-labeled murine anti-tenascin monoclonal anti-body 81C6 (M81C6) via surgically created resection cavity in the treatment of patients with recurrent malignant brain tumors.J Clin Oncol 22, no. 14_suppl (July 15, 2004): 1569.
Badruddoja MA, Reardon DA, Akabani G, Friedman AH, Friedman HS, Rich JN, Quinn JA, Penne K, Vredenburgh JJ, Bigner DD. Phase II trial of iodine 131-labeled murine anti-tenascin monoclonal anti-body 81C6 (M81C6) via surgically created resection cavity in the treatment of patients with recurrent malignant brain tumors. J Clin Oncol. 2004 Jul 15;22(14_suppl):1569.

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

July 15, 2004

Volume

22

Issue

14_suppl

Start / End Page

1569

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences