Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
Lay Description
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.
Category
- Nervous System
- Brain & Nervous System
- IRB Number
- 20180274HU
- NCT Number
- NCT03057626
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 5 Years and 50 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
Arm Groups
Study Contact
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu
Principal Investigator
Anne-Marie Langevin