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Sponsored by: |
Duke University |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002753 |
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody in treating patients with recurrent gliomas.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Radiation: iodine I 131 monoclonal antibody 81C6 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PROTOCOL FOR A PHASE I STUDY OF INTRACYSTIC ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 IN THE TREATMENT OF PATIENTS WITH RECURRENT CYSTIC GLIOMAS |
Estimated Enrollment: | 6 |
Study Start Date: | November 1991 |
OBJECTIVES: I. Assess the toxic effects of intracystic administration of iodine-131-labeled anti-tenascin monoclonal antibody 81C6. II. Identify any objective therapeutic responses to this treatment in patients with recurrent cystic anaplastic gliomas.
OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Anti-Tenascin Monoclonal Antibody 81C6, 131I-81C6.
PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.
Ages Eligible for Study: | 3 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial anaplastic glioma with a recurrent cyst requiring aspiration for symptom control Measurable cystic lesion confirmed by contrast-enhanced CT or MRI At least 3 months since radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression 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/mm3 Platelet count greater than 100,000/mm3 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: Negative pregnancy test Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic 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: See Disease Characteristics Surgery: Not specified
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: | CDR0000064689, DUMC-1965-98-12R7, DUMC-1752-96-12R5, DUMC-1775-95-12R4, DUMC-1860-97-12R6, NCI-H96-0008 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002753 History of Changes |
Health Authority: | United States: Federal Government |
childhood supratentorial ependymoma recurrent childhood brain tumor recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult myxopapillary ependymoma adult anaplastic ependymoma |
adult anaplastic oligodendroglioma adult mixed glioma adult ependymoblastoma recurrent childhood cerebral astrocytoma recurrent childhood ependymoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Immunologic Factors Astrocytoma Brain Tumor, Childhood Central Nervous System Neoplasms Ependymoma Recurrence Antibodies, Monoclonal Brain Neoplasms Neuroectodermal Tumors |
Antibodies Neoplasms, Germ Cell and Embryonal Iodine Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Immunoglobulins Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Pharmacologic Actions Antibodies, Monoclonal Neuroectodermal Tumors |
Neoplasms Antibodies Neoplasms by Site Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |