Cabozantinib With Ifosfamide in Relapsed/Refractory Sarcomas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-40
SponsorChildren's Hospital of Philadelphia
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disease that has progressed on or relapsed after upfront initial therapy, which must have included traditional chemotherapy.
Evaluable or Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), within 21 days of enrollment.
Phase I dose-finding cohort: age 12 to 40 years at the time of enrollment.
Disqualifiers
Radiographic evidence of tumor invading major blood vessels, or endotracheal or endobronchial tumor.
Radiographic evidence of tumor invading the gastrointestinal tract, including esophagus, stomach, small or large bowel, rectum, or anus.
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy or surgery (including radiosurgery) and stable for at least 4 weeks prior to enrollment after radiotherapy or major surgery (i.e. removal or biopsy of brain metastasis). Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of enrollment.
Prior progression/relapse with cabozantinib. Prior therapy with cabozantinib without progression/relapse and prior use of other multi-tyrosine kinase inhibitors is allowed.
Trial design
Treatments tested in this trial
- Cabozantinib
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
Children's Hospital Colorado
Collaborator
Alex's Lemonade Stand Foundation
Collaborator
Exelixis
Collaborator
Source ClinicalTrials.gov