Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent childhood medulloblastoma, untreated childhood medulloblastoma, adult supratentorial primitive neuroectodermal tumor (PNET), recurrent childhood supratentorial primitive neuroectodermal tumor, untreated childhood supratentorial primitive neuroectodermal tumor, adult anaplastic astrocytoma, adult diffuse astrocytoma, adult pilocytic astrocytoma, adult subependymal giant cell astrocytoma, recurrent childhood subependymal giant cell astrocytoma, untreated childhood subependymal giant cell astrocytoma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, untreated childhood cerebellar astrocytoma, adult brain stem glioma, adult mixed glioma, childhood mixed glioma, recurrent childhood brain stem glioma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood visual pathway glioma, untreated childhood brain stem glioma, untreated childhood visual pathway and hypothalamic glioma, untreated childhood visual pathway glioma, regional neuroblastoma, disseminated neuroblastoma, recurrent neuroblastoma, extraocular retinoblastoma, recurrent retinoblastoma, adult anaplastic ependymoma, adult ependymoblastoma, adult ependymoma, adult myxopapillary ependymoma, adult subependymoma, childhood infratentorial ependymoma, childhood supratentorial ependymoma, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor, recurrent melanoma, stage IV melanoma, adult medulloblastoma, chondrosarcoma, metastatic osteosarcoma, recurrent osteosarcoma, metastatic childhood soft tissue sarcoma, ovarian sarcoma, recurrent childhood soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma, adult anaplastic oligodendroglioma, adult desmoplastic small round cell tumor, adult oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, tumors metastatic to brain, adult rhabdomyosarcoma, childhood oligodendroglioma, childhood desmoplastic small round cell tumor, extensive stage small cell lung cancer, intraocular retinoblastoma, recurrent adult brain tumor, recurrent adult soft tissue sarcoma, recurrent uterine sarcoma, small intestine leiomyosarcoma, recurrent small intestine cancer, recurrent small cell lung cancer, extraocular extension melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, newly diagnosed childhood ependymoma, adult glioblastoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood pineoblastoma, untreated childhood pineoblastoma, adult pineal gland astrocytoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma, recurrent childhood anaplastic astrocytoma, untreated childhood anaplastic astrocytoma, recurrent childhood anaplastic oligoastrocytoma, recurrent childhood anaplastic oligodendroglioma, untreated childhood anaplastic oligoastrocytoma, untreated childhood anaplastic oligodendroglioma, recurrent childhood giant cell glioblastoma, recurrent childhood glioblastoma, untreated childhood giant cell glioblastoma, untreated childhood glioblastoma, recurrent childhood gliosarcoma, untreated childhood gliosarcoma, recurrent childhood gliomatosis cerebri, untreated childhood gliomatosis cerebri, childhood high-grade cerebellar astrocytoma, childhood high-grade cerebral astrocytoma
Eligibility Criteria
Inclusion Criteria:
- Patients must have a histologically confirmed diagnosis of a malignancy known to expressGD2. Such tumors include medulloblastoma/primitive neuroectodermal tumor of the CNS, high grade astrocytomas, malignant glioma, neuroblastoma, retinoblastoma, ependymoma, rhabdoid tumors, sarcomas, melanoma or small cell lung carcinoma. For patients with other tumor types, GD2 expression must be confirmed by immunohistochemical staining and assessed by the Department of Pathology using prior frozen tissue, bone marrow or CSF cytology (send to Research Lab).
- Patients must have CNS/ leptomeningeal disease including high risk medulloblastoma, or a CNS/leptomeningeal malignancy which is refractory to conventional therapies, or for which no conventional therapy exists, OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).
- Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count > 50,000/ul.
- Patients may have active malignancy outside the central nervous system.
- Patients who have a programmable shunt will not be excluded.
- Both pediatric and adult patients of any age are eligible.
- Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.
Exclusion Criteria:
- Patients with obstructive or symptomatic communicating hydrocephalus.
- Patients with an uncontrolled life-threatening infection.
- Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.
- Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.
- Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.
- Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than or equal to grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.
- Patients must have no rapidly progressing or deteriorating neurologic examination.
- Patients who have already received >45 Gy to the craniospinal radiation or >72 Gy focal brain radiation.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Experimental
131I-3F8
This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease.