I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
- Determine the response rate in patients with relapsed or refractory neuroblastoma
treated with iodine I 131 metaiodobenzylguanidine (^131I-MIBG) and combination
chemotherapy comprising carboplatin, etoposide, and melphalan followed by autologous
bone marrow or peripheral blood stem cell transplantation and radiotherapy.
- Determine the hematopoietic and nonhematopoietic toxicity of this regimen in these
- Determine the tumor self-absorbed radiation dose (TSARD) in patients with measurable
soft tissue lesions treated with this regimen.
- Correlate the TSARD with tumor response in patients with measurable residual soft
tissue disease treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to risk (poor-risk
group [mixed or no response to induction therapy or progression during or after induction
therapy] vs good-risk group [partial response after 4 courses of induction therapy]) and
kidney function at study entry (glomerular filtration rate [GFR] ≥ 100 mL/min vs GFR 60-99
- Stem cell harvest: Patients undergo a peripheral blood stem cell harvest or bone marrow
harvest provided they have an adequate number of cells available. At least 2 weeks
later, patients proceed to iodine I 131 metaiodobenzylguanidine (^131I-MIBG) and
- 131I-MIBG and combination chemotherapy: Patients receive ^131I-MIBG IV over 2 hours on
day -21, carboplatin IV continuously on days -7 to -4, etoposide IV continuously on
days -7 to -4, and melphalan IV over 1 hour on days -7 to -5.
- Stem cell infusion and filgrastim (G-CSF): Three days after completion of chemotherapy,
patients undergo transplantation of either stem cells or bone marrow on day 0. Patients
also receive G-CSF subcutaneously or IV over 1 hour once daily beginning on day 0 and
continuing until blood counts return to normal.
- Radiotherapy: Once blood counts return to normal, patients undergo radiotherapy to
primary and metastatic sites that have not received previous irradiation over 12 days
beginning after day 42.
After completion of study treatment, patients are followed for 2 years and then periodically
PROJECTED ACCRUAL: Approximately 50 patients (40 low-risk patients and 8-10 high-risk
patients) will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response (complete response, very good partial response, and partial response) at 60-days post stem cell infusion
Gregory Yanik, MD
University of Michigan Cancer Center
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Children's Hospital and Regional Medical Center - Seattle||Seattle, Washington 98105|
|Cook Children's Medical Center - Fort Worth||Fort Worth, Texas 76104|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Childrens Hospital Los Angeles||Los Angeles, California 90027|
|Lucile Packard Children's Hospital at Stanford University Medical Center||Palo Alto, California 95798|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus||Atlanta, Georgia 30322|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|C.S. Mott Children's Hospital at University of Michigan Medical Center||Ann Arbor, Michigan 48109-0286|
|Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital||Houston, Texas 77030-2399|
|University of Chicago Comer Children's Hospital||Chicago, Illinois 60637|
|Morgan Stanley Children's Hospital of New York-Presbyterian||New York, New York 10032|