RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-20
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05135975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Months to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Megan Blue, MPH
CONTACT
6147223686
megan.blue@nationwidechildrens.org
Parth Patel, MPH
CONTACT
6147224319
parth.patel2@nationwidechildrens.org

Principal Investigator

Nilay Shah, MD
PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital

Study Locations (Sites)

Children's Hospital of Alabama/UAB
Birmingham, Alabama, 35233
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Children's Hospital at Montefiore
Bronx, New York, 10467
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Primary Children's Hospital
Salt Lake City, Utah, 84113
United States

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

  • Nilay Shah, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2029-12

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • Malignant rhabdoid tumor
  • Osteosarcoma
  • Ewing sarcoma
  • Rhabdomyosarcoma
  • Desmoplastic small round blue cell tumor
  • Wilms tumor
  • Solid tumor
  • Metastatic osteosarcoma

Additional Relevant MeSH Terms

  • Neuroblastoma
  • Sarcoma