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ADI-PEG 20 with Ifosfamide and Mesna in Combination with Radiation Therapy for the Treatment of Soft Tissue Sarcoma Prior to Surgical Resection

Trial Status: active

This phase I/II trial tests the safety and effectiveness of ADI-PEG 20 with ifosfamide and mesna in combination with radiation therapy in treating patients with soft tissue sarcoma prior to surgical resection. Although most patients with soft tissue sarcomas present with localized disease (disease that has not spread to other areas in the body), some patients with intermediate- or high-grade sarcoma will develop metastatic disease (disease that has spread from where it first started to other places in the body) despite local tumor control with radiation therapy and surgical resection. Available systemic therapies have limited effectiveness for the majority of sarcoma subtypes and better therapies leading to better local and distant control are needed. ADI-PEG 20 breaks down the amino acid arginine and may block the growth of tumor cells that need arginine to grow. It is a type of iminohydrolase. Chemotherapy drugs, such as ifosfamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Mesna is a chemoprotective agent given with ifosfamide to help protect the bladder from irritation and bleeding. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving ADI-PEG 20 with ifosfamide and mesna in conjunction with radiation therapy may be a safe, tolerable and effective treatment that could lead to improved local and distant control rates of soft tissue sarcomas amenable to surgical resection.