Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma
Completed · Phase 3
Conditions studied: Neuroblastoma
In brief
RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Isotretinoin may help neuroblastoma cells become more like normal cells, and grow and spread more slowly. Giving combination chemotherapy before surgery may make the tumor smaller and make it more likely that the tumor can be surgically removed. It is not yet known what is the minimal amount of chemotherapy needed to achieve sufficient tumor shrinkage to control intermediate risk neuroblastoma and prevent tumor recurrence or metastases. PURPOSE: This phase III trial is designed to reduce therapy for patients with favorable biology intermediate risk neuroblastoma by decreasing the number of chemotherapy cycles administered and by allowing for up to 50% residual tumor volume for patients with localized disease.
Key facts
- Study ID
- NCT00499616
- Run by
- Children's Oncology Group
- People needed
- 464
- Starts
- 2007-10-08
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2021-07-06
Who can join
Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Arizona Cancer Center at University of Arizona Health Sciences Center — Tucson, Arizona, United States
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Southern California Permanente Medical Group — Downey, California, United States
- City of Hope Comprehensive Cancer Center — Duarte, California, United States
- Loma Linda University Cancer Institute at Loma Linda University Medical Center — Loma Linda, California, United States
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital — Long Beach, California, United States
- Childrens Hospital Los Angeles — Los Angeles, California, United States
- Children's Hospital Central California — Madera, California, United States
- Children's Hospital and Research Center Oakland — Oakland, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- Lucile Packard Children's Hospital at Stanford University Medical Center — Palo Alto, California, United States
- Sutter Cancer Center — Sacramento, California, United States
- University of California Davis Cancer Center — Sacramento, California, United States
- Kaiser Permanente Medical Center - Oakland — Sacramento, California, United States
- Rady Children's Hospital - San Diego — San Diego, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- Children's Hospital Center for Cancer and Blood Disorders — Aurora, Colorado, United States
- Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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