Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
a study on Neuroblastoma
Summary
- Eligibility
- for people ages 5-50 (full criteria)
- Location
- at UCSF
- Dates
- study startedcompletion around
Description
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.
Official Title
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study
Details
PRIMARY OBJECTIVES:
- 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:
- 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.
Keywords
Recurrent Neuroblastoma, Stage 2A Neuroblastoma, Stage 2B Neuroblastoma, Stage 3 Neuroblastoma, Stage 4 Neuroblastoma, Stage 4S Neuroblastoma, Neuroblastoma, Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Quality-of-Life Assessment
Eligibility
You can join if…
Open to people ages 5-50
- 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
You CAN'T join if...
- 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
Locations
- UCSF Benioff Children's Hospital Oakland
Oakland California 94609 United States - UCSF Medical Center-Mission Bay
San Francisco California 94158 United States - Children's Hospital Los Angeles
Los Angeles California 90027 United States - Kaiser Permanente-Oakland
Oakland California 94611 United States - Kaiser Permanente Downey Medical Center
Downey California 90242 United States - Lucile Packard Children's Hospital Stanford University
Palo Alto California 94304 United States - City of Hope Comprehensive Cancer Center
Duarte California 91010 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Children's Oncology Group
- ID
- NCT03057626
- Study Type
- Observational
- Participants
- About 376 people participating
- Last Updated