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

Launched by CHILDREN'S ONCOLOGY GROUP · Feb 15, 2017

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term effects of treatment in patients who have had high-risk neuroblastoma, a type of childhood cancer. The goal is to understand how different treatments impact patients over time, helping doctors to identify which treatments are easier for patients to tolerate and have fewer side effects in the long run.

To be eligible for the study, participants need to be between 18 and 26 years old and must have been diagnosed with high-risk neuroblastoma at least five years ago. They also need to have previously participated in a specific neuroblastoma research study. It’s important to note that patients who are currently receiving or have received certain chemotherapy treatments in the last two years cannot join the trial. Participants will not undergo any new treatments during the study; instead, they will share their experiences and any lasting effects from their past treatments. This research is crucial for improving future care for young patients with neuroblastoma.

Gender

ALL

Eligibility criteria

• 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