Late Effects After Treatment in Patients With Previously Diagnosed High-Risk 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.
Conditions
- Recurrent Neuroblastoma
- Stage 2A Neuroblastoma
- Stage 2B Neuroblastoma
- Stage 3 Neuroblastoma
- Stage 4 Neuroblastoma
- Stage 4S Neuroblastoma
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03057626
- Status
- Active, not recruiting
- Sponsor
- Children's Oncology Group
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.