Actively Recruiting
Cabozantinib With Ifosfamide in Relapsed/Refractory Sarcomas
Led by Children's Hospital of Philadelphia · Updated on 2025-11-14
30
Participants Needed
4
Research Sites
262 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
C
Children's Hospital Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to better understand how safe and effective the drug cabozantinib in combination with high-dose ifosfamide is in the treatment of children and adults with relapsed/refractory sarcomas.
CONDITIONS
Official Title
Cabozantinib With Ifosfamide in Relapsed/Refractory Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of any sarcoma, including bone and soft tissue sarcomas
- Disease progressed on or relapsed after initial chemotherapy
- Evaluable or measurable disease within 21 days before enrollment
- Age 12 to 40 years for phase I dose-finding cohort or 5 to less than 12 years for dose-confirmation cohort
- Body surface area greater than 0.35 m2
- Performance status Lansky play score (under 16 years) or Karnofsky score (16 years and older) of 50 or higher
- Recovery to baseline or grade less than 1 from prior toxicities, except clinically non-significant or controlled side effects
- Able to swallow tablets whole
- Absolute neutrophil count over 1,000/uL without recent growth factor use
- Hemoglobin over 8 g/dL without recent transfusion
- Platelet count over 100,000/uL without recent transfusion
- Normal renal function by specified tests
- Urine protein/creatinine ratio 1 mg/mg or less, or 24-hour urine protein 1 g or less
- Total bilirubin less than 1.5 times upper limit of normal (less than 3.0 times if Gilbert's disease)
- ALT, AST, and ALP 3 times upper limit of normal or less (ALP up to 5 times allowed with bone metastases)
- Serum albumin greater than 2.8 g/dL
- Prothrombin time and partial thromboplastin time less than 1.3 times upper limit of normal
- Agreement to use medically accepted contraception during study and for 4 months after last dose if sexually active and fertile
- Female participants of childbearing potential must not be pregnant at screening; pre-pubertal, permanently sterilized, or postmenopausal females are excepted
You will not qualify if you...
- Tumor invading major blood vessels or airway
- Tumor invading gastrointestinal tract
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- Prior progression or relapse after cabozantinib
- Prior high-dose ifosfamide therapy over 10 g/m2 per cycle
- Recent use of small molecule inhibitors, chemotherapy, immunotherapy, or radiation therapy within specified timeframes
- Recent major or minor surgery without complete wound healing
- Recent use of hematopoietic growth factors
- Allergy or hypersensitivity to study treatment components
- History of severe hemorrhagic cystitis
- Use of medications causing QTc prolongation or strong CYP3A4 interactions
- Use of certain anticoagulants except allowed low-dose aspirin or specific low molecular weight heparins
- Serious cardiovascular diseases including advanced heart failure, prolonged QT syndrome, uncontrolled hypertension, recent stroke or heart attack
- Active gastrointestinal diseases or conditions increasing risk of bowel complications
- Significant bleeding conditions or recent intracranial hemorrhage
- Other active cancers requiring treatment except certain localized skin or bladder cancers
- Other serious disorders such as non-healing wounds, severe hypothyroidism, liver impairment, immunodeficiency, severe infection, or electrolyte imbalances
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Meghan Donnelly, MPH
CONTACT
J
James Robinson, MSW, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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