Actively Recruiting
A Phase I Trial of Cabozantinib (XL184) Combined With High-dose Ifosfamide in Children and Adults With Relapsed/Refractory Sarcomas
Led by Children's Hospital of Philadelphia · Updated on 2025-11-14
30
Participants Needed
4
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of cabozantinib combined with high-dose ifosfamide in treating children and adults with relapsed or refractory sarcomas. This study focuses on sarcomas that have returned or not responded to previous treatments, aiming to understand if cabozantinib can inhibit specific proteins (MET and VEGFR2) involved in tumor growth. The trial is a Phase I study sponsored by the Children's Hospital of Philadelphia. Participants will receive cabozantinib together with high-dose ifosfamide for five treatment cycles. If participants continue to benefit, they may receive cabozantinib alone for up to a total of twelve cycles. The study includes different age groups divided into two cohorts: one for ages 12 to 40 and another for ages 5 to under 12 years. Treatment cycles last 28 days, and the study closely monitors dosing to find the maximum tolerated dose. During the study, participants will have regular assessments including scans to measure tumor response, blood tests to check blood counts and organ function, and evaluations of side effects. Researchers will track toxicities and dose-limiting side effects after each cycle and measure antitumor activity at six months. The primary outcome is to determine the recommended dose for further studies. Participation may last over a year, including safety monitoring and follow-up visits.
CONDITIONS
Brief 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 that has progressed or relapsed after initial chemotherapy
- Measurable or evaluable disease within 21 days of enrollment
- Age 12 to 40 years for dose-finding cohort; age 5 to under 12 years for dose-confirmation cohort
- Body surface area greater than 0.35 m2
- Lansky play score (under 16 years) or Karnofsky score (over 16 years) of 50 or higher
- Recovery to baseline or grade less than 1 from prior toxicities unless clinically insignificant or controlled
- Able to swallow tablets whole
- Adequate blood counts: neutrophils above 1000/uL, hemoglobin above 8 g/dL without recent transfusion, platelets above 100,000/uL without recent transfusion
- Normal renal function by specified lab criteria
- Liver function within defined limits
- Use of medically accepted contraception during study and for 4 months after
- Female subjects of childbearing potential must not be pregnant or must meet specified criteria for non-childbearing status
You will not qualify if you...
- Tumor invading major blood vessels, airway, or gastrointestinal tract
- Known untreated or unstable brain metastases
- Prior progression or relapse after cabozantinib treatment
- Prior high-dose ifosfamide therapy over 10 g/m2 per cycle
- Recent treatment with small molecule inhibitors, chemotherapy, immunotherapy, or radiation within specified timeframes
- Recent major or minor surgeries without complete wound healing
- Use of hematopoietic growth factors shortly before enrollment
- Allergy or hypersensitivity to study treatment components
- History of severe hemorrhagic cystitis
- Use of medications causing significant interactions or bleeding risks
- Certain cardiovascular diseases including severe heart failure, arrhythmias, or uncontrolled hypertension
- Active or recent gastrointestinal diseases with risk of complications
- Significant bleeding conditions or recent intracranial hemorrhage
- Other active malignancies requiring treatment within 3 years
- Serious medical disorders such as pulmonary lesions, non-healing wounds, severe infections, or immunodeficiencies
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles of 28 days each
Participants receive cabozantinib combined with high-dose ifosfamide for 5 cycles, followed by cabozantinib monotherapy for up to 12 total cycles if still on study therapy.
Visits occur with each treatment cycle
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
J
James Robinson, MSW, MPH
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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