MIBG for Refractory Neuroblastoma and Pheochromocytoma

Korábbi kezelés

• Because of the teratogenic potential of the study medication, no patients who are pregnant or lactating will be allowed. Patients of childbearing potential must practice an effective method of birth control while participating on this study, to avoid possible damage to the fetus.

Más betegség

• Patients with disease of any major organ system that would compromise their ability to withstand therapy.
• Known allergy to any of the agents or their ingredients used in this study.
• Patients with untreated positive blood cultures or progressive infections as assessed by radiographic studies

Egyéb

• Patients who are on hemodialysis

• Diagnosis:
  • Relapsed/refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical neuroblastoma cells in the bone marrow
  • Metastatic pheochromocytoma
• Age >1 year and able to cooperate with radiation safety restrictions during therapy period
• Karnofsky or Lansky performance status of ≥ 50%
• Life expectancy: ≥ at least 8 weeks
• Disease status: Failure to respond to standard therapy or development of progressive disease at any time.
• Disease must be evaluable by MIBG scan. A positive MIBG scan must be present within 8 weeks prior to study entry and subsequent to any intervening therapy. If the patient has only one MIBG positive lesion and that lesion was radiated, a biopsy must be done at least 4 weeks after radiation was completed and must show viable neuroblastoma.
• Stem Cells: Patients must have a hematopoietic stem cell product available for reinfusion after MIBG treatment at doses of > 12 mCi/kg.
• Have acceptable organ function as defined below within 7 days of enrollment:
  • Bone Marrow: ANC ≥750 X 109 /L and platelets ≥50,000 X 109 /L without transfusion if stem cells are not available (any ANC or platelet allowed if stem cells available)
  • Renal: Creatinine ≤3x upper limit of normal
  • Hepatic: Bilirubin ≤2x upper limit of normal; AST/ALT ≤10x upper limit of normal
  • Cardiac: Ejection fraction ≥45% on echocardiogram
  • Pulmonary: normal lung function as manifested by no dyspnea and/or oxygen saturation ≥ 88% on room air.
• Prior Therapy: Patients must have recovered from all acute toxicities (defined as CTCAE 4.0 ≤ grade 1) associated with any prior therapy, and:
  • Myelosuppressive chemotherapy: At least 2 weeks should have elapsed since any chemotherapy causing myelosuppression
  • Biologic (anti-neoplastic agent): At least 7 days should have elapsed since the completion of therapy with a biologic agent.
  • Monoclonal antibodies: At least 3 half-lives should have elapsed since therapy with a monoclonal antibody
  • Radiation therapy: Three-months should have elapsed in the case of completing radiation to any of the following fields: craniospinal, total abdominal, whole lung, total body irradiation). For all other sites of radiation, at least 2 weeks should have relapsed.
  • Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 24 hours prior to MIBG therapy.
• Voluntary written informed consent