Clinical Trials /

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

NCT03057626

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.

Related Conditions:
  • Neuroblastoma
Recruiting Status:

Recruiting

Trial Eligibility

Document

Title

  • Brief Title: Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
  • Official Title: LEAHRN (Late Effects After High-Risk Neuroblastoma) Study

Clinical Trial IDs

  • ORG STUDY ID: ALTE15N2
  • SECONDARY ID: NCI-2017-00170
  • SECONDARY ID: ALTE15N2
  • SECONDARY ID: COG-ALTE15N2
  • SECONDARY ID: UG1CA189955
  • NCT ID: NCT03057626

Conditions

  • Stage 2A Neuroblastoma
  • Stage 2B Neuroblastoma
  • Stage 3 Neuroblastoma
  • Stage 4 Neuroblastoma
  • Stage 4S Neuroblastoma

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.

Detailed Description

      PRIMARY OBJECTIVES:

      I. To estimate the prevalence of organ dysfunction, subsequent malignant neoplasm (SMN),
      growth impairment, abnormal pubertal development, and neurobehavioral dysfunction in a large
      cohort of representative 5-year survivors of high-risk neuroblastoma treated with modern
      therapy.

      II. To identify the demographic, clinical and treatment-related risk factors associated with
      increased risk of organ dysfunction, SMN, growth impairment, abnormal pubertal development
      and neurobehavioral dysfunction in long-term survivors of high-risk neuroblastoma.

      III. To explore the impact of new biologic therapies and diagnostics including immunotherapy,
      immunocytokines, isotretinoin (cis-retinoic acid) and iobenguane I-131 (131 I-MIBG) on the
      risk of late effects.

      IV. To determine the impact of impaired organ function, physical growth, pubertal
      development, and neurobehavioral function on health-related quality of life (HRQOL) in
      long-term survivors of high-risk neuroblastoma.

      SECONDARY OBJECTIVES:

      I. To establish a cohort of high-risk neuroblastoma survivors, with stored peripheral blood
      samples, who were treated with multi-modal therapies since the year 2000 as a resource for
      future investigation.

      OUTLINE:

      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.
    

Trial Arms

NameTypeDescriptionInterventions
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.

    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.
          
    Maximum Eligible Age:50 Years
    Minimum Eligible Age:5 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Prevalence of SMN
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Will calculate as the number of patients with SMN divided by the number with known status of that endpoint. Will be analyzed using appropriate descriptive statistics: mean, standard deviation, quartiles for continuous endpoints, proportions and confidence intervals for binary, ordinal, and categorical endpoints. Using data from ANBL00B1, a descriptive comparison will be performed of patients who did not enroll on the study versus those who did enroll, in terms of standard clinical and biological neuroblastoma risk factors from the time of diagnosis.

    Secondary Outcome Measures

    Measure:Collection and storage of blood samples
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Survivors and their families will be consented for future utilization of their banked sample for future research. Samples will be linked to clinical information but results will not be returned to the treating physician.

    Details

    Phase:N/A
    Primary Purpose:Observational
    Overall Status:Recruiting
    Lead Sponsor:Children's Oncology Group

    Last Updated

    June 6, 2017