Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma

Running, not enrolling

Conditions studied: Recurrent Neuroblastoma, Stage 2A Neuroblastoma, Stage 2B Neuroblastoma, Stage 3 Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma

In brief

This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.

Key facts

Study ID

NCT03057626

Run by

Children's Oncology Group

People needed

376

Starts

2017-06-05

Expected to finish

2026-09-30

Last updated by the study team

2026-01-09

Who can join

Age: 5 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have been enrolled on COG neuroblastoma biology study ANBL00B1
• Patient must have been diagnosed with high-risk neuroblastoma per ANBL00B1 definition
• Patient must have been diagnosed on or after January 1, 2000
• At least 5 years must have elapsed since diagnosis
• Patients must have been treated for high-risk neuroblastoma
• Note: patients may have had any therapy for high-risk neuroblastoma, including second line or non-established therapies (for example in the setting of less than optimal initial response or concerns for high risk of relapse); patients may have received therapy for refractory or relapsed neuroblastoma, or treatment for an SMN; however all cytotoxic anti-neuroblastoma therapy should have been administered >= 2 years of the enrollment date; SMN therapy may be completed or ongoing at the time of enrollment

You may not qualify if…

• Patients must not be currently receiving active anti-neuroblastoma cytotoxic chemotherapy
• Patients must not have received anti-neuroblastoma cytotoxic chemotherapy within the last two years
• Note: cytotoxic therapies include (but are not limited to) chemotherapy (platinum agents, alkylators, anthracyclines, topoisomerases, vinca alkaloids, other cytotoxic chemotherapy), any kind of transplant, MIBG therapy, and/or radiation therapy
• Non-cytotoxic (biologic/targeted/differentiating/other) therapies are permitted at the time of enrollment; for example, patients receiving oral differentiating agents, antiangiogenic therapy, immune modulators, holistic therapies, difluoromethylornithine (DMFO), other minimal residual disease (MRD) therapies/relapse-prevention therapies are eligible
• Patients with current active neuroblastoma relapse are ineligible

Where it is running

• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
• UCSF Medical Center-Mission Bay — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Broward Health Medical Center — Fort Lauderdale, Florida, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• Arnold Palmer Hospital for Children — Orlando, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
• Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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