Status:
ACTIVE_NOT_RECRUITING
Therapy for Children With Advanced Stage Neuroblastoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Cookies for Kids' Cancer
CURE Childhood Cancer, Inc.
Conditions:
Neuroblastoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief Summary
Neuroblastoma is the most common extracranial solid tumor in childhood, with nearly 50% of patients presenting with widespread metastatic disease. The current treatment for this group of high-risk pat...
Detailed Description
The phases of the study are: 1. Screening phase: Tests and evaluations will be done before treatment starts. 2. Induction phase: Includes chemotherapy plus hu14.18K322A mAb. Participants will also ha...
Eligibility Criteria
Inclusion
- PARTICIPANT
- Participants \<19 years of age (eligible until 19th birthday).
- Newly diagnosed, advanced stage, high-risk neuroblastoma defined as one of the following:
- Children \< 1 year with International Neuroblastoma Staging System (INSS) stage 2a, 2b, 3, 4 or 4S disease AND MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal).
- INSS 2a or 2b disease AND MYCN amplification, regardless of age or additional biologic features
- INSS stage 3 AND:
- MYCN amplification (\>10 copies, or greater than four-fold increase in MYCN signal as compared to reference signal, regardless of age or additional biologic features
- Age \> 18 months (\> 547 days) with unfavorable pathology, regardless of MYCN status
- INSS stage 4 and:
- MYCN amplification, regardless of age or additional biologic features
- Age \> 18 months (\> 547 days) regardless of biologic features
- Age 12 - 18 months (365 - 547 days) with any of the following three unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index =1) or any biologic feature that is indeterminant/unknown
- Children at least 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed to a stage 4 without interval chemotherapy.
- Histologic proof of neuroblastoma or positive bone marrow for tumor cells with increased urine catecholamines.
- Adequate renal and hepatic function (serum creatinine \<3 x upper limit of normal for age, AST\< 3 x upper limit of normal).
- No prior therapy, unless an emergency situation requires local tumor treatment (discuss with principal investigator).
- Written, informed consent according to institutional guidelines.
- PARTICIPANT
Exclusion
- Any evidence, as judged by the investigator, of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Pregnant or breast feeding (female of child-bearing potential).
- Children with INSS 4 disease, age \<18 months with all 3 favorable biologic features (non-amplified MYCN, favorable pathology and DNA index \>1).
- DONOR Inclusion Criteria:
- Potential donor is a biologic parent
- Potential donor is at least 18 years of age.
Key Trial Info
Start Date :
July 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01857934
Start Date
July 5 2013
End Date
December 1 2025
Last Update
November 17 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105