A Phase I Trial of Cabozantinib (XL184) in Combination With High-dose Ifosfamide in Adults and Children With Relapsed/Refractory Sarcomas (CaIRS Trial)
Children's Hospital of Philadelphia
Summary
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.
Description
In this study, the investigators will test the activity of cabozantinib in combination with high-dose ifosfamide as targeted therapy for relapsed/refractory sarcomas. Cabozantinib has been shown to inhibit multiple tyrosine kinases, including potent inhibition of kinases, MET and VEGFR2. Therefore, the goal of this study is to see if Cabozantinib can be used to inhibit MET and VEGFR2, or other tyrosine kinases to drive tumor responses in patients.
Eligibility
- Age range
- 5–40 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologic diagnosis of any sarcoma, including bone and soft tissue sarcomas. Biopsy from current relapse/progression is highly preferred, though will accept tissue from prior relapse/progression or initial diagnosis with approval from the study Principal Investigator or designee. 2. Disease that has progressed on or relapsed after upfront initial therapy, which must have included traditional chemotherapy. 3. Evaluable or Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), within 21 days of enrollment. 4. Age, within the followin…
Interventions
- DrugCabozantinib
Participants will receive cabozantinib in combination with high-dose ifosfamide for 5 cycles. If still on study therapy the participants will continue with cabozantinib monotherapy for up to 12 total cycles.
Locations (4)
- University of California San FranciscoSan Francisco, California
- Children's Hospital ColoradoAurora, Colorado
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- University of PennsylvaniaPhiladelphia, Pennsylvania