Lung Cancer Clinical Trial
Official title:
Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
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.
OBJECTIVES:
- 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.
;
Primary Purpose: Treatment
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