Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
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 study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.
Brain and Central Nervous System Tumors
Radiation: iodine I 131 monoclonal antibody 3F8
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms|
|Study Start Date:||April 1997|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
- Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
- Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.
OUTLINE: This is a dose escalation study.
Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection.
Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).
Patients are followed weekly for 4 weeks.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003022
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Kim Kramer, MD||Memorial Sloan Kettering Cancer Center|