Purpose

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

IRB Number
20180274HU
NCT Number
NCT03057626
Open to Enrollment
Yes
Sponsor
Children's Oncology Group -



Study Contact

Principal Investigator
Anne-Marie Langevin

Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu



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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional
Condition
  • Recurrent Neuroblastoma
  • Stage 2A Neuroblastoma
  • Stage 2B Neuroblastoma
  • Stage 3 Neuroblastoma
  • Stage 4 Neuroblastoma
  • Stage 4S Neuroblastoma

    • Arm Groups

    ArmDescriptionIntervention

    Observational (specimen collection)

    		Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.
  • Other: Laboratory Biomarker Analysis

    Correlative studies

  • Other: Cytology Specimen Collection Procedure

    Undergo collection of blood and urine

    Other names:

    • Cytologic Sampling

  • Other: Quality-of-Life Assessment

    Ancillary studies

    Other names:

    • Quality of Life Assessment

    •