In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with pathologically proven diagnosis of grade 2-3 (intermediate or high grade) soft tissue sarcoma of the trunk or extremities with size ≥5 cm by clinical or radiographic assessment that is appropriate for ifosfamide therapy. Patients must be planning to undergo treatment with curative intent.
* Patients with sufficient tumor tissue for correlative analyses. Patients without sufficient tissue may be allowed to enroll on a case-by-case basis with permission of sponsor-investigator.
* Staging workup shows no definitive evidence of distant metastasis and there is planned definitive surgical resection of the primary tumor.
* At least 18 years of age at time of consent.
* ECOG performance status ≤ 1
* Adequate bone marrow, coagulation, and organ function as defined below:
* Absolute neutrophil count ≥ 1.5 K/cumm
* Platelets ≥ 100 K/cumm
* Hemoglobin ≥ 9 g/dL (no transfusions within 7 days of C1D-7)
* International Normalized Ratio (INR) ≤ 1.5 x IULN or prothrombin time (PT) ≤ 1.5 x IULN, and partial thromboplastin time (aPTT or PTT) ≤ 1.5 x IULN (inclusion only applicable to subjects not using anticoagulation).
* Total bilirubin ≤ 1.5 x IULN (except for patients with Gilbert's Syndrome, who must have a total bilirubin \<3 mg/dL)
* AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
* Creatinine clearance ≥ 60 mL/min/1.73\^2 by MDRD
* The effects of the study therapy on the developing human fetus are unknown. For this reason and because chemotherapeutics…