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Clinical Trial · NCT00445965
Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer
Overview
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.
Sponsor
Memorial Sloan Kettering Cancer Center
Phase
Phase 2
Contacts
Kim Kramer, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT00445965Drug / Compound
3F8
Isotope(s):
IODINE-131
Radioisotope: I-131
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 8 Days
Decay Mode: BETA, GAMMA
Energy: βeta max 0.6 MeV Gamma 364 keV
Range: In Tissue: 0.8 -2.1 mm
Decay Daughters: Xe131
Status: FDA Approval: 1951-First FDA Approved Radiopharmaceutical), AZEDRA® (2018)
Target(s):
- GD2
Ligand Class: Antibodies
Eligibility
Inclusion
- Patients may have active malignancy outside the central nervous system.
- Patients who have a programmable shunt will not be excluded.
- Patients must have an absolute neutrophil count (ANC) \> 1000/ul and a platelet count \> 50,000/ul.
- 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).
Exclusion
- Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.
- Patients with obstructive or symptomatic communicating hydrocephalus.
- Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.
- Patients with an uncontrolled life-threatening infection.
- Patients who have already received \>45 Gy to the craniospinal radiation or \>72 Gy focal brain radiation.
- Patients must have no rapidly progressing or deteriorating neurologic examination.
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