RecruitingPhase 2NCT06540963

Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma


Sponsor

Giselle Sholler

Enrollment

98 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two drugs — tipifarnib and naxitamab — for children and young adults with neuroblastoma (a type of cancer that starts in nerve tissue, usually in young children) that has returned or stopped responding to treatment. Both drugs work on different pathways to fight cancer cells. **You may be eligible if...** - You were diagnosed with neuroblastoma at or before age 21 and are currently older than 12 months - Your cancer has relapsed (come back) or is refractory (not responding to treatment) - Your cancer has been confirmed by pathology at some point in your treatment history - Disease assessment has been performed within 4 weeks before starting the study drug **You may NOT be eligible if...** - Your tumor has not been pathologically confirmed as neuroblastoma - You have other serious health conditions that prevent participation - You have recently received certain other treatments and have not had adequate recovery time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTipifarnib

Tablet

DRUGNaxitamab

IV


Locations(12)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Connecticut Children's Hospital

Hartford, Connecticut, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Arnold Palmer Hospital for Children

Orlando, Florida, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Duke University

Durham, North Carolina, United States

Randall Children's Hospital

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center and Children's Hospital

Hershey, Pennsylvania, United States

Monroe Carrell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Dell Children's Blood and Cancer Center

Austin, Texas, United States

Children's Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06540963


Related Trials