LEAHRN (Late Effects After High-Risk Neuroblastoma) Study
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study
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.
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.
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
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
Patients with current active neuroblastoma relapse are ineligible
Minneapolis, Minnesota 55404, United States
Houston, Texas 77030, United States
Spokane, Washington 99204, United States