Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: sorafenib; Ifosfamide
Intervention description: Patients with sarcoma who have resectable disease will be treated with neoadjuvant sorafenib and ifosfamide. PET/CT will be used to assess the metabolic and radiographic response to therapy.; Patients with sarcoma who have resectable disease will be treated with neoadjuvant ifosfamide and sorafenib. PET/CT will be used to assess the metabolic and radiographic response to therapy.
Intervention MeSH terms: Sorafenib; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: localized osteosarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma

Summary:

      RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
      such as ifosfamide, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. Giving sorafenib together with
      ifosfamide may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with
      ifosfamide and to see how well it works in treating patients with high-grade soft tissue
      sarcoma or bone sarcoma that can be removed by surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed high grade sarcoma of the soft tissue or bone

          -  participants Identified as a proper candidate for ifosfamide-based neoadjuvant therapy

          -  candidates must have operable disease for which a resection is planned

          -  ECOG performance status 0-1

          -  Hemoglobin ≥ 9.0 g/dL

          -  ANC ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)

          -  INR < 1.5 or PT/PTT normal.Concurrent anticoagulation therapy with warfarin or heparin
             allowed

          -  Creatinine ≤ 1.5 times ULN

          -  women of childbearing potential must have negative pregnancy test performed within 7
             days prior to start of treatment.

          -  Fertile patients must use effective contraception during and for ≥ 2 weeks after
             completion of study therapy.

          -  A signed informed consent must be obtained prior to any study specific procedures.

        Exclusion Criteria:

          -  known HIV infection

          -  chronic hepatitis B or C infection

          -  clinically active serious infection > CTCAE grade 2

          -  NYHA class III or IV congestive heart failure

          -  unstable angina (i.e., anginal symptoms at rest) or new onset angina within the past 3
             months

          -  myocardial infarction within the past 6 months

          -  cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

          -  uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic
             BP > 90 mm Hg) despite optimal medical management

          -  thrombolic or embolic events (e.g., cerebrovascular accident, including transient
             ischemic attacks) within the past 6 months

          -  pulmonary hemorrhage or bleeding event ≥ CTCAE grade 2 within the past 4 weeks

          -  other hemorrhage or bleeding event ≥ CTCAE grade 3 within the past 4 weeks

          -  Any condition that would impair the ability to swallow whole pills

          -  malabsorption problem

          -  Any known severe hypersensitivity to sorafenib tosylate or any of its excipients

          -  known or suspected allergy to sorafenib tosylate or any agent given in this study

          -  serious nonhealing wound, ulcer, or bone fracture

          -  evidence or history of bleeding diathesis or coagulopathy

          -  significant traumatic injury within the past 4 weeks

          -  major surgery or open biopsy within 4 weeks of starting treatment

          -  Concomitant St. John's wort or rifampin

          -  KNown brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI
             of the brain to exclude brain metastases.

          -  any condition that impairs patients' ability to swallow pills

          -  any malabsorption problem