RecruitingPhase 2NCT05135975

A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors

Phase 2 Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors


Sponsor

Nationwide Children's Hospital

Enrollment

86 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will expand the types of pediatric cancers being evaluated for response to cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will extend this evaluation to tumors that have been shown to either express known targets of cabozantinib or with preclinical evidence of efficacy, including specifically neuroblastomas. These tumors have high morbidity and mortality, particularly in the relapse setting, and few or no proven therapeutic options. As such, evaluation of cabozantinib in these studies is warranted. The study hypothesizes that use of cabozantinib in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, as defined in the inclusion criteria below, can prevent and/or slow recurrent tumor formation in pediatric solid tumors and thereby significantly extend the period of disease control and/or induce a durable cure.


Eligibility

Min Age: 18 MonthsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether cabozantinib (a targeted therapy) can prevent high-risk pediatric solid tumors from coming back after treatment has brought the cancer under control. **You may be eligible if...** - You are a child or adolescent with a high-risk solid tumor that previously had measurable disease - Your most recent treatment put your cancer into remission or significantly reduced it - Your cancer is now in a stable or low-burden state **You may NOT be eligible if...** - Your cancer is currently progressing or still measurable without response to recent treatment - You do not meet the specific tumor response criteria defined in the study 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

DRUGCabozantinib

Enrolled patients will be treated with cabozantinib maleate, tablet formulation, using the recommended Phase 2 dose of 40 mg/m2/day to a maximum of 420 mg/week. Treatment will be administered in 28- day cycles.


Locations(6)

Children's Hospital of Alabama/UAB

Birmingham, Alabama, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Hospital at Montefiore

The Bronx, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT05135975


Related Trials