Monoclonal Antibody Therapy in Treating Patients With Recurrent Gliomas
|ClinicalTrials.gov Identifier: NCT00002753|
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : February 18, 2013
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Radiation: iodine I 131 monoclonal antibody 81C6||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|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|
|Study Start Date :||November 1991|
|Actual Primary Completion Date :||April 2001|
|Actual Study Completion Date :||April 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002753
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Darell D. Bigner, MD, PhD||Duke Cancer Institute|