• Return to search results
• Start new search

Investigator(s):
Robert Yarchoan, M.D. Principal Investigator Phone: 301-496-8959 yarchoan@helix.nih.gov	Thomas Uldrick, M.D. Lead Associate Investigator Phone: 301-496-8959 uldrickts@mail.nih.gov
Referral Contact(s):
Kathy Wyvill, R.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 wyvillk@mail.nih.gov	Karen Aleman, R.N., B.S.N. Research Nurse Phone: 301-496-8959 1-800-243-2732 ext. 4 (Toll Free) Fax: 301-402-7552 alemank@mail.nih.gov

---

Primary Eligibility:

• Pathologically confirmed advanced Kaposi sarcoma (KS), meeting one of the following criteria:
• HIV-negative
• HIV-positive with stable KS despite 1 year of highly active antiretroviral therapy (HAART) with HIV viremic control
• HIV-positive with progressive KS despite 4 months of HAART with HIV viremic control
• Other advanced AIDS-associated KS
• Aged ≥ 18 years
• Evaluable disease involving the skin and/or viscera, including at least one of the following:
• KS of the skin with ≥ 5 KS lesions that are evaluable by non-invasive methods that have not been treated with local therapeutic modalities
• Pulmonary KS evaluable by CT scan
• Gastrointestinal KS evaluable by direct visualization or fiberoptic instrumentation
• Biopsy-proven lymph node involvement measurable by CT scan
• At least one of the following indications for therapy: pulmonary involvement, visceral involvement, pain, edema, substantial lymph node involvement, ulcerating lesions, decreased range of joint motion due to KS, multiple lesions not amenable to local therapy, significant psychological impact leading to social withdrawal
• No mass lesions in the brain
• ECOG performance status 0–2
• Life expectancy > 6 months
• Hemoglobin > 9 g/dL, WBC > 1,000/mm³, ANC > 750/mm³, platelet count > 75,000/mm³, PT and PTT ≤ 120% of control (unless a lupus anticoagulant is present)
• Bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin ≤ 7.5 mg/dL and direct bilirubin ≤ 0.7 mg/dL in patients receiving protease inhibitor therapy [e.g., indinavir, ritonavir, nelfinavir, or atazanavir])
• AST/ALT ≤ 2.5 x ULN
• Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
• Urine protein < 1+ by urine dipstick OR urine protein < 500 mg by 24-hour urine collection
• Not pregnant or nursing; fertile patients must use effective contraception prior to, during, and for 12 weeks after completion of study therapy
• Patients with HIV infection must be willing to comply with a regimen of HAART
• Systolic BP < 150 mm Hg and diastolic BP < 90 mm Hg; patients receiving anti-hypertensive medication must be on a stable regimen for at least 1 month
• Ejection fraction > 50% by MUGA scan
• No surgical or other non-healing wounds other than KS ulcers
• No uncontrolled illness
• No history of arterial thrombotic disease
• No substantial CNS disease
• No other condition that, in the opinion of the investigator, would preclude the inclusion of a patient onto this study

---

Study Outline:

• Patients receive bevacizumab IV over 90 minutes on Days 1 and 8 and pegylated liposomal doxorubicin hydrochloride IV over 30 minutes on Day 8 of Course 1
• Beginning in Course 2 and all subsequent courses, patients receive bevacizumab IV over 90 minutes followed by pegylated liposomal doxorubicin hydrochloride IV over 30 minutes on Day 1
• Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
• Patients with stable disease or better will proceed to maintenance therapy
• Patients receive bevacizumab IV over 90 minutes on Day 1
• Treatment repeats every 3 weeks for 11 courses in the absence of disease progression or unacceptable toxicity
• Patients undergo blood sample collection periodically for analysis of HIV viral load levels, lymphocyte phenotype TBNK, and KSHV viral load levels; patients also undergo saliva sample collection periodically for analysis of KSHV viral load levels
• After completion of study therapy, patients are followed at 4 weeks and then every 3 months for up to 2 years

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/12/09
Updated: 8/4/09