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Brain and Central Nervous System Tumors | Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer

Brain and Central Nervous System Tumors research study

What is the primary objective of this study?

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal metastases. PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Brain and Central Nervous System Tumors

Intraocular Melanoma

Lung Cancer

Melanoma (Skin)

Metastatic Cancer

Neuroblastoma

Ovarian Cancer

Retinoblastoma

Sarcoma

Small Intestine Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Genetic:DNA analysis

Other:immunologic technique

Other:pharmacological study

Radiation:iodine I 131 monoclonal antibody 3F8

Radiation:131I-3F8Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

131I-3F8This 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.

Study Status

Active, not recruiting

Start Date: January 2006

Completed Date: January 2019

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Six-month overall survival

Secondary Outcome: cumulative toxicities

Study sponsors, principal investigator, and references

Principal Investigator: Kim Kramer, MD

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00445965

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