Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma (NCT06540963)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment/neuroblastoma protocol) and has now relapsed and is in any number of relapses. Refractory disease defined as High-risk neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRG) that failed to achieve complete response (CR) after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy, or with disease remaining after standard immunotherapy. INRG High Risk NB defined as one of the following:
5. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification
6. Age ≥ 547 days and INRG Stage M regardless of biologic features
7. Any age initially diagnosed with INRG Stage L1 MYCN amplified neuroblastoma (NBL) who have progressed to Stage M without systemic chemotherapy
8. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy
9. Measurable Disease: Subjects must be relapsed or refractory with active disease. Subjects must have measurable or evaluable disease, including at least one of the following: Measurable tumor \>10mm by computed tomography scan (CT) or magnetic resonance imaging (MRI); a positive metaiodobenzylguanidine (MIBG) scan or positron emission tomography (PET) scan or Positive bone marrow biopsy/aspirate.
10. Subjects with central nervous system (CNS) disease currently taking steroids must have been on a stable dose of steroids for at least one week prior to their biopsy and must not have progressive hydrocephalus at enrollment.
11. Timing from prior therapy: Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:
12. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (12 Sites)

• Arkansas Children's Hospital — Little Rock, Arkansas
• Connecticut Children's Hospital — Hartford, Connecticut
• Nicklaus Children's Hospital — Miami, Florida
• Arnold Palmer Hospital for Children — Orlando, Florida
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii
• Cardinal Glennon Children's Medical Center — St Louis, Missouri
• Duke University — Durham, North Carolina
• Randall Children's Hospital — Portland, Oregon
• Penn State Milton S. Hershey Medical Center and Children's Hospital — Hershey, Pennsylvania
• Monroe Carrell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee
• Dell Children's Blood and Cancer Center — Austin, Texas
• Children's Medical Center — Dallas, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.