OncoMatch/Clinical Trials/NCT05135975
A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors
Is NCT05135975 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cabozantinib for neuroblastoma.
Treatment: Cabozantinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Sarcoma
Prior therapy
Cannot have received: myelosuppressive chemotherapy
Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment on study (6 weeks if prior therapy included nitrosourea)
Cannot have received: non-myelosuppressive anticancer agents (including any type of small molecule kinase inhibitor)
Patients must not have received non-myelosuppressive anticancer agents, including any type of small molecule kinase inhibitor, within 14 days of enrollment on study
Cannot have received: biological anticancer therapy (including antibody therapy or cellular therapy)
Patients must not have received biological anticancer therapy within 21 days of enrollment on study
Cannot have received: external beam radiation therapy to sites outside of the lungs
Patients must not have received external beam radiation therapy to sites outside of the lungs within 2 weeks of study enrollment
Cannot have received: external beam radiation therapy to sites within the lungs
external beam radiation therapy to sites within the lungs within 4 weeks of study enrollment
Cannot have received: I-131 MIBG therapy
I-131 MIBG therapy within 6 weeks of study enrollment
Cannot have received: myeloablative therapy
Patients must not have received myeloablative therapy within 2 months of study enrollment
Cannot have received: blood stem cell/marrow infusion
must not have received a blood stem cell/marrow infusion within 3 weeks of study enrollment
Lab requirements
Blood counts
ANC ≥1000/mcL (no filgrastim/pegfilgrastim/biosimilar within 14 days); Platelet count ≥ 100,000/mcL (≤15 mL/kg transfusions per week; TPO agonist allowed if stable ≥14 days); Hemoglobin ≥ 8.0 g/dL (≤10 mL/kg PRBCs/week; erythropoietin allowed if stable ≥14 days, no PRBCs)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 OR serum creatinine based on age/gender; Urine protein ≤ 30 mg/dl or ≤ 1+ on dipstick OR quantitative urine protein < 1000 mg in 24hr urine
Liver function
Total bilirubin < 2x institutional ULN for age; ALT <5x ULN; Serum albumin >2.7 g/dL
Cardiac function
No significant arrhythmias, strokes, TIA, or MI within 6 months; QTc ≤ 480 msec; BP ≤ 95th percentile for age/height/gender (<18y) or ≤140/90 (≥18y); one antihypertensive agent allowed if stable ≥2 weeks
See Section 3.2.3, criteria 5-9
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital of Alabama/UAB · Birmingham, Alabama
- Children's Hospital of Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
- Children's Hospital at Montefiore · The Bronx, New York
- Nationwide Children's Hospital · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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