Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
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.
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.
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