Actively Recruiting
A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors
Led by Nationwide Children's Hospital · Updated on 2025-08-12
86
Participants Needed
6
Research Sites
384 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 months to less than 40 years at enrollment
- Lansky or Karnofsky performance status score of 50 or higher (ECOG 0, 1, or 2)
- Body surface area equal to or greater than 0.35 m2 within two weeks of enrollment
- Recovery from acute toxic effects of prior therapies with specific time intervals since last treatments
- Adequate bone marrow function with specified blood count thresholds and stable marrow disease if present
- Adequate renal function based on creatinine clearance or serum creatinine and urine protein limits
- Adequate liver function with total bilirubin less than 2 times upper limit of normal, ALT less than 5 times upper limit, and serum albumin over 2.7 g/dL
- Adequate cardiovascular function with no significant events in past 6 months, QTc less than or equal to 480 msec, and blood pressure within age-appropriate limits
- Adequate pancreatic function with serum lipase less than 2 times upper limit of normal
- Stable neurologic function if seizures present, with use of non-enzyme inducing anticonvulsants
- No invasive pulmonary procedures or pneumothorax within 4 weeks before enrollment
- No major surgery, trauma, or central line/port procedures within specified timeframes before enrollment
- Surgical wounds or incisions must be healed prior to enrollment
- Ability to swallow tablets intact
- Agreement to use contraception during and for 4 months after study treatment if sexually active and fertile
- Ability to understand and comply with protocol and provide informed consent
- Ability to start study treatment no later than 12 weeks after end of prior therapy and within 7 days of enrollment
- Enrollment within 14 days of qualifying imaging showing best response
You will not qualify if you...
- Patients with ongoing complications from prior radiation therapy without clearance from study chair
- Use of filgrastim, pegfilgrastim, or equivalent within 14 days prior to enrollment
- Receipt of myelosuppressive chemotherapy within 3 weeks (or 6 weeks if nitrosourea) prior to enrollment
- Receipt of non-myelosuppressive anticancer agents within 14 days prior to enrollment
- Receipt of biological anticancer therapy within 21 days prior to enrollment
- Receipt of external beam radiation to non-lung sites within 2 weeks, to lung sites within 4 weeks, or I-131 MIBG therapy within 6 weeks prior to enrollment
- Receipt of myeloablative therapy within 2 months prior to enrollment
- Receipt of blood stem cell/marrow infusion within 3 weeks prior to enrollment
- Inadequate blood counts or unstable bone marrow disease
- Significant cardiovascular events (arrhythmias, stroke, MI) within 6 months prior to enrollment
- QTc interval greater than 480 msec after repeat testing
- Blood pressure above age-appropriate limits not controlled by stable antihypertensive therapy
- Pancreatic function impairment with elevated serum lipase
- Use of enzyme-inducing anticonvulsants
- Invasive pulmonary procedures or pneumothorax within 4 weeks prior to enrollment
- Major surgical procedures, sepsis, shock, trauma requiring hospitalization within 4 weeks prior to enrollment
- Central line or port placement, revision, or removal (excluding PICC) within 7 days prior to enrollment
- Core or fine needle biopsy within 7 days prior to enrollment
- Unhealed surgical wounds or incisions at enrollment
- Inability to swallow tablets intact
- Pregnancy or non-compliance with contraception requirements
- Inability to understand or comply with study protocol
- Treatment start delayed beyond allowed windows after prior therapy or enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Children's Hospital of Alabama/UAB
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Children's Hospital at Montefiore
The Bronx, New York, United States, 10467
Actively Recruiting
5
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
Actively Recruiting
Research Team
M
Madeline Richardson, MA
CONTACT
P
Parth Patel, MPH, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here