Sunitinib in Certain Subtypes of Soft Tissue Sarcomas
Condition: Sarcoma, Soft Tissue
MeSH terms: Sarcoma
Intervention: Sunitinib
Intervention description: Taken daily PO for a 42 day cycle. This cycle is repeated at least twice.
A small molecule, multi-targeted receptor tyrosine kinase inhibitor that selectively targets and intracellularly blocks the signaling pathways of receptor tyrosine kinase (RTKs).
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the clinical response rate (complete response and
      partial response) in patients with metastatic, locally advanced, or locally recurrent
      vascular soft tissue sarcoma treated with sunitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically-proven diagnosis of angiosarcoma, epithelioid sarcoma-like
             hemangioendothelioma or Kaposi's sarcoma. Both HIV-Related and HIV-Unrelated Kaposi's
             patients will be included in the trial. Patients with HIV-Related Kaposi's will be
             required to have a CD4 count >50 cells/µL and Viral Load < 50 copies/ml. They will
             also need to be willing to take HAART. They can either have stable Kaposi's on HAART
             for at least 3 months or have progression of their Kaposi's after having been on HAART
             for at least 10 weeks.

          -  Not amenable to surgery, radiation, or combined modality treatment with curative
             intent.

          -  Evidence of unidimensionally measurable disease by conventional radiographic
             techniques. In patients with Kaposi's sarcoma, skin lesions at least 10 mm will be
             considered measurable disease. Bone lesions, ascites, or lymphangitis of skin or lung
             are not considered measurable.

          -  No more than 2 prior chemotherapy regimens for metastatic or unresectable disease.
             Patients may have received prior bevacizumab or other Tyrosine Kinase Inhibitors,
             excluding sunitinib. Treatment with bevacizumab or other Tyrosine Kinase Inhibitors
             will not be counted as prior chemotherapy regimens.

          -  Four weeks since prior chemotherapy, surgery or radiation therapy and resolution of
             all toxic effects of any prior therapy, surgical procedure or radiation.

          -  ECOG performance status 0-2.

          -  Age 18 or greater.

        Exclusion Criteria:

          -  Patients with a "currently active" second malignancy other than non-melanoma skin
             cancer or carcinoma in situ of the cervix are not to be registered. Patients who are
             not considered to have a "currently active" malignancy if they have completed therapy
             and are considered by their physician to be at less than 30% risk of relapse.

          -  No areas of measurable disease by CT or MRI.

          -  Any of the following within the 6 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, or cerebrovascular accident. or transient
             ischemic attack, or pulmonary embolism.

          -  Ongoing cardiac dysrhythmias, atrial fibrillation or prolongation of the QTc interval
             to >450 msec for males of > 470 msec for females. Medications that may prolong the QT
             intervals should be discontinued or switched to another medication prior to starting
             Sutent unless determined by the investigator to be absolutely necessary.

          -  Pregnancy or breastfeeding.

          -  Other severe acute or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with the study participation or
             study drug administration.

          -  Major surgery or radiation therapy within 4 weeks of starting the study treatment.