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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Nationwide Children's Hospital
Study ID
NCT05135975
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 20, 2022
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
86 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    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.

Primary Outcome Measure

To evaluate the effect of oral daily cabozantinib, administered for up to 12 months, on the one-year progression-free survival of patients with "ultra-high-risk" pediatric solid tumors. [ Time Frame: 4 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital of Alabama/UABBirminghamAlabama35233
Elizabeth Alva, MD, MSPH
[email protected]
205-638-9285
Children's Hospital of ColoradoAuroraColorado80045
Emily Blauel, MD
[email protected]
720-777-6740
Children's National Medical CenterWashington D.C.District of Columbia20010
Kim AeRang, MD
[email protected]
202-476-2800
Children's Hospital at MontefioreThe BronxNew York10467
Alice Lee, MD
[email protected]
Nationwide Children's HospitalColumbusOhio43205
Kelly Hadinger
[email protected]
6143551231
Nilay Shah, MD (PRINCIPAL_INVESTIGATOR)
Primary Children's HospitalSalt Lake CityUtah84113
Matthew Dietz, MD
[email protected]
801-662-4700

Find similar trials in Birmingham, AL

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
Children's Hospital of Alabama/UAB· Birmingham, ALChildren's Hospital of Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCChildren's Hospital at Montefiore· The Bronx, NYNationwide Children's Hospital· Columbus, OHPrimary Children's Hospital· Salt Lake City, UT

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