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Therapeutic Areas: Oncology | Pediatrics/Neonatology | Neurology
Disease Category: Neuroblastoma

Trial Information

A medical study for children with relapsed or refractory high-risk Neuroblastoma.

This phase IIa trial is studying the side effects and best dose of Ultratrace™ iodine I 131 MIBG followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk Neuroblastoma.

DISEASE CHARACTERISTICS:

• Histologically confirmed neuroblastoma
  • Histological confirmation is not required if tumor cells are present in the bone marrow with increased urinary catecholamine metabolites
• High-risk neuroblastoma, meeting at least 1 of the following criteria:
  • Recurrent/progressive disease at any time
  • Refractory disease (i.e., less than a partial response to frontline therapy, including a minimum of 4 courses of chemotherapy)
• Iodine I 131 metaiodobenzylguanidine (^131I-MIBG) evaluable disease, defined as evidence of uptake into tumor at = one site within 6 weeks prior to study entry and subsequent to any intervening therapy
• Adequate stem cell product available, meeting 1 of the following criteria:
  • Purged peripheral blood stem cells (PBSC) at a minimum dose of 2.0 x 10^6 viable CD34+ cells/kg
  • Unpurged PBSC at a minimum dose of 2.0 x 10^6 CD34+ cells/kg
  • Autologous bone marrow at a minimum dose of 1 x 10^8 mononuclear cells/kg
    • Immunocytology post purging must be done on purged autologous bone marrow and be negative for tumor; immunocytology is not required for peripheral blood stem cells
• Patients with prior parenchymal brain lesions/spinal cord lesions or leptomeningeal tumor are eligible provided these lesions resolved within 4 weeks prior to study entry (confirmed by CT scan or MRI)

PATIENT CHARACTERISTICS:

• Age 1 year - 30 years
• Life expectancy = 8 weeks
• Lansky or Karnofsky performance score 60-100%
• Hemoglobin > 8 g/dL (transfusion allowed)
• ANC = 750/µL
• Platelet count = 20,000/µl (transfusion independent, defined as no platelet transfusion within the past two weeks)
• Serum creatinine = 1.5 times normal for age as defined below:
  • No greater than 0.8 mg/dL (for patients = 5 years of age)
  • No greater than 1.0 mg/dL (for patients 6-10 years of age)
  • No greater than 1.2 mg/dL (for patients 11-15 years of age)
  • No greater than 1.5 mg/dL (for patients 16 years of age and over)
• Total bilirubin = 1.5 times normal for age
• SGPT (ALT) and SGOT (AST) = 3 times normal for age
• Normal ejection fraction (i.e., = 50%) by echocardiogram or radionuclide MUGA evaluation OR normal fractional shortening (i.e., = 27%) by echocardiogram
• Normal lung function with no dyspnea at rest, exercise intolerance, pleural effusion, or oxygen requirement
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Patients with other ongoing serious medical issues must be approved by the study chair prior to study entry
• Able to comply with the safety monitoring requirements of the study in the opinion of the investigator
• Patients and/or families must be physically and psychologically able to cooperate with the radiation safety isolation or imaging requirements (sedation or general anesthesia permitted)
• A patient weight that would require exceeding a maximum total allowable dose of ^131I-MIBG is not allowed
• No known allergy to iobenguane, iodine, or SSKI
• No disease of any major organ system that would preclude study treatment
• No renal obstruction that would effect the urinary excretion of ^131I-MIBG

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
• More than 2 weeks since prior radiotherapy
• More than 3 months since prior large-field radiotherapy (i.e., craniospinal therapy, total lung, or > 50% of the marrow space)
• More than 3 months since prior autologous stem cell transplantation
• More than 12 months since prior carrier-added ^131I-MIBG therapy
• More than 7 days since prior cytokines or hematopoietic growth factor therapy
• More than 30 days since prior therapeutic investigational compound and/or medical device
• No prior radiotherapy to the only site of measurable disease
• No prior allogeneic stem cell transplantation
• No prior whole abdominal radiotherapy or total-body irradiation
• No concurrent hemodialysis that would effect the urinary excretion of 131I-MIBG
• No other concurrent cancer chemotherapy or immunomodulating agents (including steroids)
  • Steroids may be used in the prevention and treatment of transfusion/infusion reactions and for the treatment of edema associated with CNS lesions

Clinical Trials Office- Texas Children's Hospital, Study Nurse
Texas Children's Hospital, Baylor College of Medicine
6621 Fannin St., CC1410.00
Houston, TX
Phone: 832-824-4670

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