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

Children's Oncology Group

Status: Active, not recruiting

Conditions: Recurrent Neuroblastoma; Stage 4S Neuroblastoma; Stage 3 Neuroblastoma; Stage 2B Neuroblastoma; Stage 2A Neuroblastoma; Stage 4 Neuroblastoma

Treatments: Other: Cytology Specimen Collection Procedure; Other: Quality-of-Life Assessment; Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT03057626

COG-ALTE15N2 (Other Identifier)

NCI-2017-00170 (Registry Identifier)

UG1CA189955 (U.S. NIH Grant/Contract)

ALTE15N2 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 376 patients

Sex: All

Ages: 5 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

376 participants in 1 patient group

Observational (specimen collection)

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Quality-of-Life Assessment

Other: Cytology Specimen Collection Procedure