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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003461 |
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors Neuroblastoma |
Drug: astatine At 211 monoclonal antibody 81C6 Procedure: surgical procedure |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic Brain Tumors |
Study Start Date: | February 1998 |
OBJECTIVES:
OUTLINE: This is a dose escalation study.
Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.
Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 3 of 6 patients experience dose limiting toxicity.
Patients are followed initially at 4 weeks, then at approximately 12 weeks, at 24 weeks, and then every 12 weeks for 1 year.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 18-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
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: | CDR0000066493, DUMC-2237-01-12R4, DUMC-0013-00-1R2, DUMC-0036-99-1R1, DUMC-060-98-1, DUMC-2237-00-12R3, DUMC-98007, NCI-5P50NS20023, NCI-G98-1462 |
Study First Received: | November 1, 1999 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00003461 |
Health Authority: | United States: Federal Government |
localized resectable neuroblastoma recurrent neuroblastoma recurrent adult brain tumor adult craniopharyngioma adult medulloblastoma adult meningioma adult glioblastoma adult oligodendroglioma adult tumors metastatic to brain |
adult anaplastic astrocytoma adult mixed glioma adult pineal parenchymal tumor adult central nervous system germ cell tumor adult grade III meningioma adult pilocytic astrocytoma adult giant cell glioblastoma adult gliosarcoma adult pineal gland astrocytoma |
Glioblastoma Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Brain Diseases Neuroblastoma Dental Caries Antibodies, Monoclonal Neoplasms, Germ Cell and Embryonal Craniopharyngioma Neuroepithelioma Meningioma Glioma Nervous System Neoplasms |
Immunoglobulins Astrocytoma Central Nervous System Diseases Recurrence Brain Neoplasms Neuroectodermal Tumors Antibodies Medulloblastoma Oligodendroglioma Gliosarcoma Pinealoma Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Immunologic Factors Physiological Effects of Drugs |
Neoplasms, Nerve Tissue Nervous System Diseases Neoplasms, Neuroepithelial Pharmacologic Actions |