Evaluation of Abemaciclib and Radiation Therapy Before Surgery for the Treatment of High-Risk Adipocytic Retroperitoneal Sarcoma
Trial Parameters
Brief Summary
This phase I trial tests the safety, side effects, and best dose of abemaciclib and how well it works with radiation therapy before surgery in treating patients with high-risk adipocytic retroperitoneal sarcoma. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving abemaciclib together with radiation therapy before surgery may shrink tumors in patients with high-risk adipocytic retroperitoneal sarcoma.
Eligibility Criteria
Inclusion Criteria: * Subjects, \>= 18 years old, must have newly diagnosed or locally recurrent MDM2 or CDK4-amplified adipocytic sarcoma as determined by fluorescence in situ hybridization (FISH), or other clinically appropriate methodology in the opinion of the reviewing pathologist. Histologic or imaging evidence of the presence of a dedifferentiated component must be present * Subjects must have one or more measurable target lesions by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), assessed via CT scan or MRI * At the time of study enrollment, subjects must have a tumor burden that is judged to be surgically resectable * Have plans to undergo neoadjuvant radiation therapy followed by surgical resection. Review and approval of final treatment plans for subjects receiving radiotherapy locally/at an outside institution must be reviewed and approved by a radiation oncologist investigator prior to initiation of radiotherapy * Absolute neutrophil count (ANC) \>=