A Phase II Study of Cabozantinib and Temozolomide in Patients with Unresectable or Metastatic Leiomyosarcoma and Other Soft Tissue Sarcomas

Protocol No
Principal Investigator
John Charlson
The purpose of this study is to determine if Cabozantinib, given together with Temozolomide is able to stop or reduce the rate of cancer growth in participants with your kind of cancer better than Temozolomide alone. Both drugs are considered investigational. Preclinical and clinical evidence shows that adding antiangiogenic agents (substances, drugs, or compounds which get rid of parts of the blood vessels needed by tumors to grow and spread) to chemotherapy enhances anti-tumor and antiangiogenic effects. We believe the combination of Cabozantinib with oral Temozolomide may have the potential to shrink your cancer cells or lower the chance of your cancer cells growing and spreading. An investigational drug means that the drug is not approved by the US FDA for the tumor type that is being investigated in this study. Cabozantinib is approved by the FDA for hepatocellular carcinoma and renal cancer while Temozolomide is approved to treat adult patients with glioblastoma multiforme (GBM) and anaplastic astrocytoma. This study will also look at any possible side effects that this combination of Temozolomide and Cabozantinib may have.
Cabozantinib and Temozolomide for the Treatment of Unresectable or Metastatic Leiomyosarcoma or Other Soft Tissue Sarcoma
Participating Institutions
Froedtert Hospital