Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers
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Purpose
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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.
- Determine the objective therapeutic response of these patients treated with this regimen.
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.
Eligibility| 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
- Newly diagnosed or recurrent
- No diffusely infiltrating or multifocal tumor
- No tumor with subependymal spread
- Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study
Measurable lesion on enhanced CT scan or MRI
- No measurable enhancing lesion greater than 1.0 cm beyond cavity margin
- Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody
PATIENT CHARACTERISTICS:
Age:
- 3 and over
Performance status:
- Karnofsky 50-100%
Hematopoietic:
- Absolute neutrophil count greater than 1,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 1.5 times normal
- Alkaline phosphatase less than 1.5 times normal
Renal:
- Creatinine less than 1.2 mg/dL
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progression
Endocrine therapy:
- Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry
Radiotherapy:
- At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression
Surgery:
- See Disease Characteristics
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
Additional Information:
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00002752 History of Changes |
| Other Study ID Numbers: | Pro00004635, 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, CDR0000064688 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Duke University:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neoplastic Processes Pathologic Processes Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013