Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma
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| ClinicalTrials.gov Identifier: NCT03057626 |
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Recruitment Status :
Active, not recruiting
First Posted : February 20, 2017
Last Update Posted : February 13, 2023
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| Condition or disease | Intervention/treatment |
|---|---|
| Recurrent Neuroblastoma Stage 2A Neuroblastoma Stage 2B Neuroblastoma Stage 3 Neuroblastoma Stage 4 Neuroblastoma Stage 4S Neuroblastoma | Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment |
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.
| Study Type : | Observational |
| Actual Enrollment : | 376 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | LEAHRN (Late Effects After High-Risk Neuroblastoma) Study |
| Actual Study Start Date : | June 5, 2017 |
| Actual Primary Completion Date : | September 30, 2021 |
| Estimated Study Completion Date : | September 30, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Cytology Specimen Collection Procedure
Undergo collection of blood and urine Other: Laboratory Biomarker Analysis Correlative studies Other: Quality-of-Life Assessment Ancillary studies |
- Prevalence of specific late effects [ Time Frame: Up to 3 years ]Late effects of interest are organ dysfunction, subsequent malignant neoplasms (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction. Prevalence will be calculated as the number of patients with late effects divided by the number with known status of that endpoint.
- Risk factors of late effects [ Time Frame: Up to 3 years ]Risk factors of interest include sex, race, ethnicity, current age, length of follow up, MYCN status, stage, primary site, age at diagnosis, total anthracycline dose (doxorubicin equivalents), cyclophosphamide dose equivalent categories, total platinum exposure (dose), topotecan exposure (yes [Y]/no [N]), cis-retinoic acid exposure (Y/N), GD-2/cytokine exposure (Y/N), radiation (Y/N), abdominal RT (Y/N), radiation to metastatic sites (Y/N), number of transplants, number of meta-iodobenzylguanidine (MIBG) scans, and therapeutic MIBG (Y/N). Will be reported as the number of patients with the risk factor divided by the number with known status of that risk factor for categorical variables and descriptively (mean, standard deviation) for continuous variables.
- Pediatric Quality of Life (PedsQL) score [ Time Frame: Up to 3 years ]PedsQL score will be reported descriptively (mean, standard deviation). The proportion of patients with impaired physical growth, delayed pubertal development, chronic disease, impaired executive functioning, and impaired social functioning will also be reported.
- Collection and storage of blood samples [ Time Frame: Up to 3 years ]Proportion of survivors and their families that consent for future utilization of their banked sample for future research will be reported.
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 5 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057626
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| Principal Investigator: | Tara O Henderson | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT03057626 |
| Other Study ID Numbers: |
ALTE15N2 NCI-2017-00170 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) ALTE15N2 ( Other Identifier: Children's Oncology Group ) COG-ALTE15N2 ( Other Identifier: DCP ) ALTE15N2 ( Other Identifier: CTEP ) UG1CA189955 ( U.S. NIH Grant/Contract ) |
| First Posted: | February 20, 2017 Key Record Dates |
| Last Update Posted: | February 13, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |