Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms

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

Intervention / Treatment
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* Radiation: iodine I 131 monoclonal antibody 3F8


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: iodine I 131 monoclonal antibody 3F8|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic osteosarcoma, childhood infratentorial ependymoma, recurrent childhood rhabdomyosarcoma, childhood supratentorial ependymoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, recurrent neuroblastoma, retinoblastoma, intraocular retinoblastoma, extraocular retinoblastoma, recurrent retinoblastoma, extensive stage small cell lung cancer, recurrent small cell lung cancer, recurrent osteosarcoma, recurrent adult brain tumor, iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, adult brain stem glioma, adult medulloblastoma, stage IV melanoma, recurrent melanoma, metastatic childhood soft tissue sarcoma, recurrent childhood soft tissue sarcoma, adult myxopapillary ependymoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult mixed glioma, localized unresectable neuroblastoma, adult ependymoblastoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood visual pathway glioma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma, adult oligodendroglioma, adult anaplastic astrocytoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult diffuse astrocytoma, adult pilocytic astrocytoma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma