Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Memorial Sloan Kettering Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin)Neuroblastoma Retinoblastoma Sarcoma

Interventions

iodine I 131 monoclonal antibody 3F8RADIATION

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed malignancy expressing GD2, including, but not limited to: * Medulloblastoma/primitive neuroectodermal tumor of the CNS * Malignant glioma * Neuroblastoma * Retinoblastoma * Ependymoma * Sarcoma * Melanoma * Small cell lung carcinoma * Other tumor types must have GD2 expression confirmed by immunohistochemical staining * Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists * Prior measurable human anti-mouse monoclonal antibody titer allowed PATIENT CHARACTERISTICS: Age: * 3 and over Performance status: * Not specified Life expectancy: * At least 2 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 Hepatic: * Bilirubin less than 3 mg/dL Renal: * Creatinine less than 2 mg/dL * Blood urea nitrogen less than 30 mg/dL Other: * May have active malignancy outside the central nervous system * No obstructive hydrocephalus * No CNS grade 3 or 4 toxicity as a consequence of prior treatments * No life threatening infection PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior monoclonal antibody treatment allowed Chemotherapy: * Prior chemotherapy allowed * Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy allowed * At least 6 weeks since prior cranial or spinal irradiation Surgery: * Not specified

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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