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| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-1533-02-8R5ER | Other Identifier | Duke University IRB | |
| DUMC-1533-01-8R4 | Other Identifier | Duke University IRB | |
| DUMC-1373-97-9 | Other Identifier | Duke University IRB | |
| DUMC-1408-98-9R1 | Other Identifier | Duke University IRB | |
| DUMC-1533-00-8R3 | Other Identifier | Duke University IRB | |
| DUMC-1570-99-9R2 | Other Identifier | Duke University IRB | |
| DUMC-97107 | Other Identifier | Duke University Cancer Protocol Committee | |
| 5P0NS20023 | Other Grant/Funding Number | National Cancer Institute | |
| NCI-G98-1472 | Other Grant/Funding Number | National Cancer Institute | |
| CDR0000066522 | Other Identifier | National Cancer Institute Record Identifier |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody after radiation therapy in treating patients with newly diagnosed primary brain tumors that can be surgically resected.
OBJECTIVES:
OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6).
Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical resection of the tumor or brain metastasis, at which time an indwelling intracranial resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the intralesional catheter.
Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.
After the MTD has been established, patients in the phase II portion of the study receive therapy as in phase I.
Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy. Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the absence of disease progression.
Patients are followed initially at 4 weeks, then every 6 weeks for 1 year.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carmustine | Drug | |||
| irinotecan hydrochloride | Drug | |||
| surgical procedure | Procedure | |||
| iodine I 131 monoclonal antibody 81C6 | Radiation |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
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 University | 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 |
| D009447 | Neuroblastoma |
| D001932 | Brain Neoplasms |
| D003397 | Craniopharyngioma |
| D008527 | Medulloblastoma |
| D008579 | Meningioma |
| D005909 | Glioblastoma |
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D010871 | Pinealoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| 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 |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
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| ID | Term |
|---|---|
| D002330 | Carmustine |
| D000077146 | Irinotecan |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D009607 | Nitrosourea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D009603 | Nitroso Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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