Sorafenib and Ifosfamide in Treating Patients With High-Grade Soft Tissue Sarcoma or Bone Sarcoma That Can Be Removed by Surgery

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ifosfamide; Isophosphamide mustard; Niacinamide; Sorafenib

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