Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
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|ClinicalTrials.gov Identifier: NCT00003022|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 3, 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 study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Neuroblastoma Retinoblastoma Sarcoma||Radiation: iodine I 131 monoclonal antibody 3F8||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms|
|Study Start Date :||April 1997|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
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): 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|