Study on ADI-PEG 20, Ifosfamide, and Radiation Therapy Before Surgery for Soft Tissue Sarcoma

Sponsor: Washington University School of Medicine

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05813327

Provider View

This clinical trial is testing a combination of ADI-PEG 20, ifosfamide, and radiation therapy given before surgery to see if it can help treat soft tissue sarcoma. The study will first determine the best dose and then evaluate how effective the treatment is.

Patient Parameters

Program Overview

In this study, patients with soft tissue sarcoma (STS) will receive a combination of ADI-PEG 20, ifosfamide, and radiation therapy before surgery. The first phase of the study will test different doses to find the most suitable one for further research. Once the best dose is identified, the second phase will focus on assessing how well the treatment works in controlling the cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with intermediate or high-grade soft tissue sarcoma of the trunk or limbs, at least 5 cm in size, and suitable for ifosfamide treatment.
  • Planning to undergo treatment with the goal of curing the cancer.
  • Have enough tumor tissue available for additional analyses, or may be allowed to participate with special permission if tissue is insufficient.
  • No evidence of cancer spread to distant parts of the body, and surgery is planned to remove the primary tumor.
  • At least 18 years old.
  • In good general health with an ECOG performance status of 0 or 1.
  • Adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 K/cumm.
    • Platelet count of at least 100 K/cumm.
    • Hemoglobin level of at least 10 g/dL without recent transfusions.
    • Normal blood clotting times.
    • Liver and kidney function within specified limits.
  • Agree to use effective birth control during the study and for 12 months after, due to potential risks to a developing fetus.
  • Able to understand and willing to sign a consent form to participate in the study.

Exclusion Criteria

  • Have low-grade soft tissue sarcoma, Kaposi sarcoma, bone sarcomas, cartilage sarcomas, or GIST.
  • Have cancer that has spread to other parts of the body, except for small lung nodules under 5 mm.
  • Currently receiving other experimental treatments.
  • Have allergies to similar drugs used in the study.
  • Have had chemotherapy for the same cancer, unless it was over three years ago and side effects have resolved.
  • Have had radiation therapy to the same area that would overlap with the study treatment.
  • Have significant bleeding issues or are taking certain blood thinners that cannot be stopped safely.
  • Taking certain medications or supplements that are restricted during the study.
  • Have an active infection requiring IV antibiotics recently.
  • Have serious heart conditions or recent heart issues.
  • Pregnant or breastfeeding women, or women who have not had a recent negative pregnancy test.
  • Have active Hepatitis B, C, or HIV infections.

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