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| Sponsor: | Duke Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003461 |
Purpose
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 |
|---|---|---|
|
Brain and Central Nervous System Tumors Metastatic Cancer Neuroblastoma |
Procedure: surgical procedure Radiation: astatine At 211 monoclonal antibody 81C6 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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.
Eligibility| 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:
Contacts and Locations| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Study Chair: | Darell D. Bigner, MD, PhD | Duke Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00003461 History of Changes |
| Other 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: | December 13, 2011 |
| 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 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 |
|
Brain Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nervous System Neoplasms Neuroblastoma Central Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplastic Processes Pathologic Processes Neuroectodermal Tumors, Primitive, Peripheral |
Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |