Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
Status: Recruiting
Phase:
DFCI Protocol ID: 17-726
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston
Overall PI:
Lisa Diller, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.orgEligibility 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
- The patient or a parent/guardian must have receptive and expressive language skills in
English, French, or Spanish since the assessment instruments are available in these
languages only. If the patient is over the age of 18 and does not have expressive
language skills it is permitted for a parent/guardian to complete the forms.