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Sponsored by: |
Duke University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002752 |
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors Metastatic Cancer |
Radiation: iodine I 131 monoclonal antibody 81C6 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS |
Study Start Date: | February 1993 |
OBJECTIVES:
OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs no).
Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 2 years, every 2 months for 2 years, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 3-6 patients per cohort will be accrued for this study.
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven primary or metastatic malignant supratentorial anaplastic glioma
Measurable lesion on enhanced CT scan or MRI
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Study Chair: | Darell D. Bigner, MD, PhD | Duke University |
Study ID Numbers: | CDR0000064688, DUMC-2426-01-2R8, DUMC-000223-00-2R7, DUMC-0328-99-2R6, DUMC-221-96-2R3, DUMC-307-97-2R4, DUMC-307-98-2R5, NCI-H96-0009 |
Study First Received: | November 1, 1999 |
Last Updated: | August 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00002752 History of Changes |
Health Authority: | United States: Federal Government |
childhood supratentorial ependymoma recurrent childhood brain tumor recurrent adult brain tumor adult medulloblastoma adult glioblastoma tumors metastatic to brain childhood high-grade cerebral astrocytoma adult anaplastic astrocytoma adult myxopapillary ependymoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult mixed glioma |
adult pilocytic astrocytoma adult subependymoma adult ependymoblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma newly diagnosed childhood ependymoma recurrent childhood ependymoma adult oligodendroglioma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Neuroectodermal Tumors, Primitive Immunologic Factors Astrocytoma Brain Tumor, Childhood Central Nervous System Neoplasms Recurrence Ependymoma Antibodies, Monoclonal Brain Neoplasms Neuroectodermal Tumors |
Antibodies Neoplasm Metastasis Medulloblastoma Iodine Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Immunoglobulins |
Immunologic Factors Nervous System Diseases Physiological Effects of Drugs Central Nervous System Neoplasms Pharmacologic Actions Antibodies, Monoclonal Neoplastic Processes |
Neoplasms Antibodies Pathologic Processes Neoplasms by Site Neoplasm Metastasis Nervous System Neoplasms |