Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
Giselle Sholler
Summary
The purpose of this study is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the Food and Drug Administration (FDA) approved drug, naxitimab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy, it may not be approved in the type of disease used in this study. The goals of this part of the study are: * Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer * To determine the activity of study treatments chosen based on: * How each subject responds to the study treatment * How long a subject lives without their disease returning/progressing
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age: Subjects must be age ≤ 21 years at initial diagnosis. Subjects must be \>12 months of age at enrollment. Safety Run-In (first 6 subjects) must be age 6 years or older. 2. Pathology: All subjects must have a pathologically confirmed diagnosis of neuroblastoma at any point in their treatment. 3. Tumor assessment: Disease staging must be performed. This disease assessment is required for eligibility and must be done within a maximum of 4 weeks before first dose of study drug. 4. Disease Status: Relapsed/Refractory Neuroblastoma Relapsed disease defined as neurobla…
Interventions
- DrugTipifarnib
Tablet
- DrugNaxitamab
IV
Locations (12)
- Arkansas Children's HospitalLittle Rock, Arkansas
- Connecticut Children's HospitalHartford, Connecticut
- Nicklaus Children's HospitalMiami, Florida
- Arnold Palmer Hospital for ChildrenOrlando, Florida
- Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii
- Cardinal Glennon Children's Medical CenterSt Louis, Missouri