Phase II Trial of Murine 131I-Labeled Anti-Tenascin Monoclonal Antibody 81C6 Administered Into Surgically Created Resection Cavities of Patients With Newly Diagnosed Malignant Gliomas

2.50
Hdl Handle:
http://hdl.handle.net/10755/165548
Category:
Abstract
Type:
Presentation
Title:
Phase II Trial of Murine 131I-Labeled Anti-Tenascin Monoclonal Antibody 81C6 Administered Into Surgically Created Resection Cavities of Patients With Newly Diagnosed Malignant Gliomas
Author(s):
Regalado, Lorna
Author Details:
Lorna Regalado, Clinnical Trials Monitor, Duke University Medical Center, Durham, Nort Carolina, USA, email: regal001@mc.duke.edu
Abstract:
Despite decades of intensive investigation, improvement in outcome for patients with the most common primary adult brain tumor, malignant glioma, remains elusive. A major factor contributing to poor outcome is failure to eliminate local tumor growth as indicated by 90% of glioblastoma multiforme (GBM) recurrences developing at or adjacent to the site of origin. Consequently, adjuvant therapies designed to enhance local control are critically needed. One approach is the delivery of radionuclides to tumor-associated antigens via monoclonal antibodies (mAbs). 81C6 is a murine IgG2b mAb that attaches to tenascin, a tumor-associated extracellular matrix glycoprotein that is present in high-grade gliomas as well as melanomas, breast, lung, and squamous cell carcinomas. The purpose of the study was to determine toxicity of intra-resection cavity 131I-labeled murine anti-tenascin monoclonal antibody 81C6 and to identify therapeutic responses to this treatment. In this phase II trial, 120 mCi of 131I-labeled murine 81C6 was injected directly into a surgically created resection cavity of 33 patients with newly diagnosed malignant gliomas (glioblastoma multiforme, n = 27; anaplastic astrocytoma, n = 4; anaplastic oligodendroglioma, n = 2) followed by conventional external beam radiotherapy and chemotherapy. The primary endpoint was the percentage of patients who survived for one year after treatment with 131I-labeled murine 81C6. To estimate survival distributions the Kaplan and Meier method was used. The median survival for all patients was 86.7 weeks and 79.4 weeks for those with GBM. Eleven patients were alive at median follow-up of 93 weeks. Toxicity was measured using the National Cancer Institute Common Toxicity Criteria version 2.0. Nine patients experienced reversible hematologic toxicities. Five patients developed histologically confirmed, treatment-related neurologic toxicities, and one patient required re-operation for radiation necrosis. Our results demonstrate that 131I-labeled 81C6 mAb therapy significantly improves survival and a phase III randomized study is warranted. Oncology nurses will be involved with patient care and symptom management after radiolabeled mAb treatment. A thorough understanding of radiolabeled mAb therapy is critical for improvement of quality patient care.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2002
Conference Name:
27th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Washington, D.C., USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titlePhase II Trial of Murine 131I-Labeled Anti-Tenascin Monoclonal Antibody 81C6 Administered Into Surgically Created Resection Cavities of Patients With Newly Diagnosed Malignant Gliomasen_GB
dc.contributor.authorRegalado, Lornaen_US
dc.author.detailsLorna Regalado, Clinnical Trials Monitor, Duke University Medical Center, Durham, Nort Carolina, USA, email: regal001@mc.duke.eduen_US
dc.identifier.urihttp://hdl.handle.net/10755/165548-
dc.description.abstractDespite decades of intensive investigation, improvement in outcome for patients with the most common primary adult brain tumor, malignant glioma, remains elusive. A major factor contributing to poor outcome is failure to eliminate local tumor growth as indicated by 90% of glioblastoma multiforme (GBM) recurrences developing at or adjacent to the site of origin. Consequently, adjuvant therapies designed to enhance local control are critically needed. One approach is the delivery of radionuclides to tumor-associated antigens via monoclonal antibodies (mAbs). 81C6 is a murine IgG2b mAb that attaches to tenascin, a tumor-associated extracellular matrix glycoprotein that is present in high-grade gliomas as well as melanomas, breast, lung, and squamous cell carcinomas. The purpose of the study was to determine toxicity of intra-resection cavity 131I-labeled murine anti-tenascin monoclonal antibody 81C6 and to identify therapeutic responses to this treatment. In this phase II trial, 120 mCi of 131I-labeled murine 81C6 was injected directly into a surgically created resection cavity of 33 patients with newly diagnosed malignant gliomas (glioblastoma multiforme, n = 27; anaplastic astrocytoma, n = 4; anaplastic oligodendroglioma, n = 2) followed by conventional external beam radiotherapy and chemotherapy. The primary endpoint was the percentage of patients who survived for one year after treatment with 131I-labeled murine 81C6. To estimate survival distributions the Kaplan and Meier method was used. The median survival for all patients was 86.7 weeks and 79.4 weeks for those with GBM. Eleven patients were alive at median follow-up of 93 weeks. Toxicity was measured using the National Cancer Institute Common Toxicity Criteria version 2.0. Nine patients experienced reversible hematologic toxicities. Five patients developed histologically confirmed, treatment-related neurologic toxicities, and one patient required re-operation for radiation necrosis. Our results demonstrate that 131I-labeled 81C6 mAb therapy significantly improves survival and a phase III randomized study is warranted. Oncology nurses will be involved with patient care and symptom management after radiolabeled mAb treatment. A thorough understanding of radiolabeled mAb therapy is critical for improvement of quality patient care.en_GB
dc.date.available2011-10-27T12:20:39Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:20:39Z-
dc.conference.date2002en_US
dc.conference.name27th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationWashington, D.C., USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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