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.org

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

  -  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.

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