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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: | NCT00003478 |
RATIONALE: Monoclonal antibodies can locate tumor cells and deliver radioactive tumor-killing substances such as radioactive iodine to them without harming normal cells.
PURPOSE: This randomized phase I/II trial is studying the side effects, best way to give, and best dose of radiolabeled monoclonal antibody and to see how well it works in treating patients with primary brain tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: iodine I 131 monoclonal antibody 81C6 Procedure: conventional surgery Procedure: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors |
Estimated Enrollment: | 10 |
Study Start Date: | October 1997 |
OBJECTIVES:
OUTLINE: This is a randomized, dose-escalation study.
Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 (I 131 MAb 81C6) by one of two delivery techniques first, then crossover to receive the antibody by the other technique 3 days later. Each patient then receives a therapeutic dose by the most efficient method. Both methods are delivered via a stereotactically-placed intralesional catheter.
Patients with newly diagnosed tumors for which no effective conventional therapy exists, such as malignant glial tumors, are treated with external beam radiotherapy within 4 months after I 131 MAb 81C6 infusion. Patients with recurrent tumors receive no other therapy unless tumor progresses.
Patients are followed at 4, 8, 16, and 24 weeks and then every 12 weeks for one year.
PROJECTED ACCRUAL: At least 10 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Radiographic evidence of a single lesion 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: | CDR0000066515, DUMC-1529-01-8R4, DUMC-1363-97-9, DUMC-1409-98-9R1, DUMC-1529-00-8R3, DUMC-1630-99-9R2, DUMC-97112, NCI-5950NS20023, NCI-G98-1471 |
Study First Received: | November 1, 1999 |
Last Updated: | November 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00003478 |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult brain stem glioma adult medulloblastoma adult glioblastoma adult anaplastic astrocytoma adult anaplastic ependymoma |
adult anaplastic oligodendroglioma adult mixed glioma adult ependymoblastoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Ependymoma Recurrence Antibodies, Monoclonal Brain Neoplasms |
Antibodies Medulloblastoma Iodine Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Immunoglobulins |
Neoplasms Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Nervous System Diseases Pharmacologic Actions |