Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma

Exclusion Criteria

• •1. Inability to provide informed consent.
• •2. KS therapy other than HAART within 3 weeks.
• •3. History of cumulative doxorubicin or liposomal doxorubicin dose \>430 mg/m(2).
• •4. Supraphysiologic doses of corticosteroids within 3 weeks.
• •5. Major surgical procedure (including periodontal) within 4 weeks.
• •6. Surgical or other non-healing wounds, other than KS ulcers.
• •7. Pregnancy (because of unknown potential for fetal malformation).
• •8. Breast feeding (because of unknown potential for adverse infant developmental consequences).
• •9. Has an uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, cirrhosis, or psychiatric illness/social situations that would limit adherence to study requirements.
• •10. Past or present history of malignant tumors other than KS unless: a) in a complete remission for greater than or equal to 1 year from the time a response was first documented; b) completely resected basal cell carcinoma; or c) in situ squamous cell carcinoma of the cervix or anus
• •11. Severe or life-threatening infection within 2 weeks of entry onto the study.
• •12. History of deep venous or arterial thrombotic disease (including but not limited to, acute myocardial infarction due to coronary thrombosis, ischemic stroke, and peripheral arterial disease), unless:
• •* Line-related thrombosis without embolus
• •* Occurring greater than or equal to 1 year prior to screening
• •13. Known procoagulant disorder including prothrombin gene mutation 20210, antithrombin III deficiency, protein c deficiency, protein S deficiency and antiphospholipid syndrome but not including heterozygosity for the Factor V Leiden mutation or the presence of a lupus anticoagulant in the absence of other criteria for the antiphospholipid syndrome.
• •14. Known bleeding diathesis.
• •15. History of severe gastrointestinal bleeding within 6 months. Patients with gastrointestinal blood loss due to KS may be included.
• •16. Hemoptysis within 4 weeks.
• •17. Substantial central nervous system (CNS) disease including.
• •* History of CNS bleeding.
• •* Mass lesions in the brain.
• •* Uncontrolled seizure disorder.
• •* Recent history of cerebrovascular accident (CVA) (e.g. within the past 6 months).
• •18. Proteinuria \> 500 mg/24hrs.
• •19. Patients with any other abnormality that would be scored as a grade 3 or greater toxicity, except:
• •* Lymphopenia
• •* Direct manifestations of KS
• •* Direct manifestation of HIV
• •* Direct manifestation of HIV therapy (i.e. Hyperbilirubinemia associated with protease inhibitors)
• •* Asymptomatic hyperuricemia
• •* Hypophosphatemia
• •20. Previous bevacizumab within 6 weeks prior to enrollment.
• •21. Known hypersensitivity to bevacizumab, Chinese hamster ovary cell products, or other recombinant human or humanized antibodies.
• •22. Any other condition, including the presence of laboratory abnormalities, which in the opinion of the Principal Investigator or Lead Associate Investigator, places the subject at unacceptable risk if there were to participate in the study or confounds the ability to interpret data from the study.