Irinotecan, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
A Phase 2 Randomized Study of Irinotecan/Temozolomide/Dinutuximab With or Without Eflornithine (DFMO) in Children With Relapsed, Refractory or Progressive Neuroblastoma
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Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Parker, Melanie; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321.841.5357 ; 321-843-1036 ; 321-843-5284 ; 3218412008 ; 321-841-7561
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IRB No: ANBL1821
Protocol Abbrev: ANBL1821
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase II
Age Group: Pediatric
Secondary Protocol No: ANBL1821
Treatment: Biological: Dinutuximab Drug: Eflornithine Drug: Irinotecan Biological: Sargramostim Drug: Temozolomide
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT03794349
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Objective
To determine whether administration of eflornithine (DFMO) in combination with dinutuximab, irinotecan hydrochloride (irinotecan) and temozolomide results in an improved response rate compared to dinutuximab, irinotecan and temozolomide in patients with relapsed or refractory neuroblastoma and therefore is a therapeutic regimen worthy of further testing in patients with newly-diagnosed high-risk neuroblastoma.
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Key Eligibility
Ages Eligible for Study: 1 Year and older (Child, Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
• Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e. > 2 x upper limit of normal [ULN]), at the time of initial diagnosis.
