Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
Completed · Phase 3
Conditions studied: Localized Resectable Neuroblastoma, Localized Unresectable Neuroblastoma, Recurrent Neuroblastoma, Regional Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma
In brief
This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.
Key facts
- Study ID
- NCT00567567
- Run by
- Children's Oncology Group
- People needed
- 665
- Starts
- 2007-11-05
- Expected to finish
- 2022-03-31
- Last updated by the study team
- 2022-04-28
Who can join
Age: any, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:
- Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:
- MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
- Age > 18 months (i.e., > 547 days) regardless of biologic features
- Age 12-18 months (i.e., 365-547 days) with none of the following three favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and deoxyribonucleic acid [DNA] index > 1)
- Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:
- MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
- Age > 18 months (i.e., > 547 days) with unfavorable pathology, regardless of MYCN status
- Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
- Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
- Patients >= 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy
- Must have been enrolled on COG-ANBL00B1
- Creatinine clearance or radioisotope glomerular filtration rate ? 70mL/min OR serum creatinine based on age/gender as follows:
- 1 month to < 6 months: 0.4 mg/dL
- 6 months to < 1 year: 0.5 mg/dL
- 1 to < 2 years: 0.6 mg/dL
- 2 to < 6 years: 0.8 mg/dL
- 6 to < 10 years: 1 mg/dL
- 10 to < 13 years: 1.2 mg/dL
- 10 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
- Total bilirubin ? 1.5 times upper limit of normal (ULN) for age
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 10 times ULN for age
- Not pregnant or nursing
- Negative pregnancy test
Where it is running
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
- USA Health Strada Patient Care Center — Mobile, Alabama, United States
- Phoenix Childrens Hospital — Phoenix, Arizona, United States
- The University of Arizona Medical Center-University Campus — Tucson, Arizona, United States
- Arkansas Children's Hospital — Little Rock, Arkansas, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Kaiser Permanente Downey Medical Center — Downey, California, United States
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- Loma Linda University Medical Center — Loma Linda, California, United States
- Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- Valley Children's Hospital — Madera, California, United States
- Children's Hospital and Research Center at Oakland — Oakland, California, United States
- Kaiser Permanente-Oakland — Oakland, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
- Rady Children's Hospital - San Diego — San Diego, California, United States
- UCSF Medical Center-Mount Zion — San Francisco, California, United States
- UCSF Medical Center-Parnassus — San Francisco, California, United States
- Harbor-University of California at Los Angeles Medical Center — Torrance, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
- Children's Hospital of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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