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

  • STATUS
    Recruiting
  • days left to enroll
    76
  • participants needed
    400
  • sponsor
    Children's Oncology Group
Updated on 25 December 2020
Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (7.7 mi away) Contact
+73 other location
high-risk neuroblastoma

Summary

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.

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.

Details
Treatment laboratory biomarker analysis, quality-of-life assessment, cytology specimen collection procedure
Clinical Study IdentifierNCT03057626
SponsorChildren's Oncology Group
Last Modified on25 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 5 yrs and 50 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage 3 Neuroblastoma or Stage 2B Neuroblastoma or Recurrent Neuroblastoma or Stage 4S Neuroblastoma or Stage 4 Neuroblastoma or Stage 2A Neuroblastom...?
Do you have any of these conditions: Recurrent Neuroblastoma or Metastatic Neuroblastoma or Stage 2A Neuroblastoma or Stage 4S Neuroblastoma or Stage 2B Neuroblastoma or Stage 3 Neuroblas...?
Do you have any of these conditions: Stage 4 Neuroblastoma or Stage 2A Neuroblastoma or Stage 3 Neuroblastoma or Stage 4S Neuroblastoma or Recurrent Neuroblastoma or Metastatic Neuroblast...?
Do you have any of these conditions: Stage 3 Neuroblastoma or Stage 2A Neuroblastoma or Stage 4S Neuroblastoma or Stage 4 Neuroblastoma or Recurrent Neuroblastoma or Stage 2B Neuroblastom...?
Do you have any of these conditions: Stage 2A Neuroblastoma or Stage 4S Neuroblastoma or Metastatic Neuroblastoma or Stage 3 Neuroblastoma or Stage 2B Neuroblastoma or Stage 4 Neuroblasto...?
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
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