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

NCT03057626 · tracked via the Priya Life Science Australia tracker

Sponsor

Children's Oncology Group

Phase

Observational

Started

2017-06-05

Last updated

2026-01-09

Condition(s) studied

Recurrent NeuroblastomaStage 2A NeuroblastomaStage 2B NeuroblastomaStage 3 NeuroblastomaStage 4 NeuroblastomaStage 4S Neuroblastoma

Investigational drug(s) / intervention(s)

Cytology Specimen Collection ProcedureLaboratory Biomarker AnalysisQuality-of-Life Assessment

Cytology Specimen Collection Procedure: Undergo collection of blood and urine

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Study summary

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.

Eligibility

Sex

ALL

Min age

5 Years

Max age

50 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Prevalence of specific late effects — Up to 3 years
Late effects of interest are organ dysfunction, subsequent malignant neoplasms (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction. Prevalence will be calculated as the number of patients with late effects divided by the number with known status of that endpoint.
Risk factors of late effects — Up to 3 years
Risk factors of interest include sex, race, ethnicity, current age, length of follow up, MYCN status, stage, primary site, age at diagnosis, total anthracycline dose (doxorubicin equivalents), cyclophosphamide dose equivalent categories, total platinum exposure (dose), topotecan exposure (yes \[Y\]/no \[N\]), cis-retinoic acid exposure (Y/N), GD-2/cytokine exposure (Y/N), radiation (Y/N), abdominal RT (Y/N), radiation to metastatic sites (Y/N), number of transplants, number of meta-iodobenzylguanidine (MIBG) scans, and therapeutic MIBG (Y/N). Will be reported as the number of patients with the risk factor divided by the number with known status of that risk factor for categorical variables and descriptively (mean, standard deviation) for continuous variables.
Pediatric Quality of Life (PedsQL) score — Up to 3 years
PedsQL score will be reported descriptively (mean, standard deviation). The proportion of patients with impaired physical growth, delayed pubertal development, chronic disease, impaired executive functioning, and impaired social functioning will also be reported.

Trial sites (98)

Facility	City	Region
Children's Hospital of Alabama	Birmingham	Alabama
Phoenix Childrens Hospital	Phoenix	Arizona
Arkansas Children's Hospital	Little Rock	Arkansas
Kaiser Permanente Downey Medical Center	Downey	California
City of Hope Comprehensive Cancer Center	Duarte	California
Children's Hospital Los Angeles	Los Angeles	California
UCSF Benioff Children's Hospital Oakland	Oakland	California
Kaiser Permanente-Oakland	Oakland	California
Lucile Packard Children's Hospital Stanford University	Palo Alto	California
UCSF Medical Center-Mission Bay	San Francisco	California
Children's Hospital Colorado	Aurora	Colorado
Connecticut Children's Medical Center	Hartford	Connecticut
Yale University	New Haven	Connecticut
Alfred I duPont Hospital for Children	Wilmington	Delaware
Children's National Medical Center	Washington D.C.	District of Columbia
Broward Health Medical Center	Fort Lauderdale	Florida
Golisano Children's Hospital of Southwest Florida	Fort Myers	Florida
University of Florida Health Science Center - Gainesville	Gainesville	Florida
Nemours Children's Clinic-Jacksonville	Jacksonville	Florida
AdventHealth Orlando	Orlando	Florida
Arnold Palmer Hospital for Children	Orlando	Florida
Nemours Children's Hospital	Orlando	Florida
Johns Hopkins All Children's Hospital	St. Petersburg	Florida
Saint Joseph's Hospital/Children's Hospital-Tampa	Tampa	Florida
Children's Healthcare of Atlanta - Egleston	Atlanta	Georgia
Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
Lurie Children's Hospital-Chicago	Chicago	Illinois
University of Illinois	Chicago	Illinois
University of Chicago Comprehensive Cancer Center	Chicago	Illinois
Advocate Children's Hospital-Oak Lawn	Oak Lawn	Illinois
Advocate Children's Hospital-Park Ridge	Park Ridge	Illinois
Saint Jude Midwest Affiliate	Peoria	Illinois
Blank Children's Hospital	Des Moines	Iowa
University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
University of Kentucky/Markey Cancer Center	Lexington	Kentucky
Norton Children's Hospital	Louisville	Kentucky
Children's Hospital New Orleans	New Orleans	Louisiana
Sinai Hospital of Baltimore	Baltimore	Maryland
Massachusetts General Hospital Cancer Center	Boston	Massachusetts
Dana-Farber Cancer Institute	Boston	Massachusetts

+ 58 more sites — see the full list on the official registry below.

More Children's Oncology Group trials in Australia

Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations Active, not recruiting

A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT) Recruiting

Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL) Active, not recruiting

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome Active, not recruiting

Other trials for the same condition

Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03057626 on ClinicalTrials.gov ↗ ← All trials in Australia