RecruitingPhase 2

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

United States98 participantsStarted 2024-12-06

Plain-language 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

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria

✓. Age:
✓. Pathology: All subjects must have a pathologically confirmed diagnosis of neuroblastoma at any point in their treatment.
✓. 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.
✓. 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.
✓. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification
✓. Age ≥ 547 days and INRG Stage M regardless of biologic features
✓. Any age initially diagnosed with INRG Stage L1 MYCN amplified neuroblastoma (NBL) who have progressed to Stage M without systemic chemotherapy
✓. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy

Exclusion criteria

What they're measuring

Determine the Overall Response Rate (ORR) of Participants using INSS Response

Timeframe: 6 months

Trial details

NCT IDNCT06540963

SponsorGiselle Sholler

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-01

Contact for this trial

BCC Enroll

7175310003 BCCEnroll@pennstatehealth.psu.edu

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