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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-2426-01-2R8 | Other Identifier | DUMC | |
| DUMC-000223-00-2R7 | Other Identifier | DUMC | |
| DUMC-0328-99-2R6 | Other Identifier | DUMC | |
| DUMC-221-96-2R3 | Other Identifier | DUMC | |
| DUMC-307-97-2R4 | |||
| DUMC-307-98-2R5 | |||
| NCI-H96-0009 | |||
| CDR0000064688 | Other Identifier | NCI |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iodine I 131 monoclonal antibody 81C6 | Radiation |
DISEASE CHARACTERISTICS:
Histologically proven primary or metastatic malignant supratentorial anaplastic glioma
Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study
Measurable lesion on enhanced CT scan or MRI
Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Darell D. Bigner, MD, PhD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D008527 | Medulloblastoma |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| D018315 | Glioma, Subependymal |
| D018242 | Neuroectodermal Tumors, Primitive |
| C531673 | Familial ependymoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| D009385 |
| Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |