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Clinical Trial Details

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Brief Title Study of MLN8237 in Combination With Irinotecan and Temozolomide
Official Title Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma
Principal Investigator Cohn, Susan
Brief Summary The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide. The goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan, and temozolomide.
Gender Both
Ages 12 Months
Enrollment 44
Accepts Healthy Volunteers No
Lead Sponsor New Approaches to Neuroblastoma Therapy ConsortiumOther
Collaborator
Study Design Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1/Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Neuroblastoma
Detail for Health Professional (on clinicaltrials.gov)
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