Bevacizumab to Treat Kaposi's Sarcoma in HIV-Positive and HIV-Negative Patients

Completed · Phase 2

Conditions studied: Kaposi's Sarcoma, HIV Infections, HIV Seronegativity

In brief

This study will examine the safety and effectiveness of the experimental drug bevacizumab for treating both non-acquired immune deficiency syndrome (AIDS) and AIDS-associated Kaposi's sarcoma (KS). KS tumors depend on the formation of new blood vessels for their growth. Bevacizumab is an antibody to a protein called vascular endothelial growth factor (VEGF) that is produced by the body and is involved in blood vessel growth. Bevacizumab may block the action of VEGF, and thus help shrink KS lesions. Patients 18 years of age and older with Kaposi's sarcoma that is restricted to the skin and is not life threatening may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, and, if needed, imaging studies to evaluate internal tumors. Participants will receive bevacizumab intravenously (by vein) once a week for 2 weeks and then every 3 weeks at the National Institutes of Health (NIH) Clinical Center. The first infusion takes about 90 minutes, the second takes about 60 minutes, and subsequent infusions take about 30 minutes. Infusions may take longer, however, if the drug is better tolerated at a slower infusion rate. Patients will be evaluated with the following tests and procedures: * Physical examination, assessment of drug side effects, measurement of KS lesions, and photographs of lesions once a week for the first 6 weeks of therapy, and then every 3 weeks. * cluster of differentiation 4 (CD4) cell counts and human immunodeficiency virus (HIV) viral load in HIV-positive patients every 12 weeks. * Biopsies of lesions: upon entering the study, at week 12, and at the time of a response of the tumor to therapy or at the end of treatment, if treatment ends at week 18 or later. * Additional biopsies, if requested. (Additional biopsies are not required.) * Other procedures, such as computed tomography (CT) or magnetic resonance imaging (MRI) scans, if medically indicated. Patients may continue bevacizumab therapy indefinitely if they are benefiting from it, as long as they have no substantial toxicity or other conditions that would cause them to stop receiving it and the protocol remains open.

Key facts

Study ID

NCT00055237

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2003-02-26

Expected to finish

2010-03-15

Last updated by the study team

2017-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Symptomatic, extensive pulmonary involvement.
• Symptomatic visceral KS excluding the oral cavity.
• Inability to provide informed consent.
• Chemotherapy within 3 weeks.
• Prior therapy with SU5416.
• Supraphysiologic doses of corticosteroids within 3 weeks.
• Major surgical procedure (including periodontal) within 4 weeks.
• Surgical or other non-healing wounds unrelated to KS.
• Pregnancy.
• Breast feeding.
• 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.
• Evidence of a severe or life-threatening infection within 2 weeks of entry onto the study.
• A condition that would require the patient to receive intravenous antibiotics on a day of bevacizumab infusion.
• Need for chronic daily aspirin greater than or equal to 325 mg/daily or nonsteroidal medication interfering with platelet function.
• Therapeutic anticoagulation with international normalized ratio (INR) greater than 1.5, unless the patient is on full dose warfarin. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
• The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of low molecular weight (LMW) heparin;
• The subject must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels).
• History of deep venous or arterial thrombosis.
• History of gastrointestinal bleeding.
• Clinically significant cardiovascular disease such as uncontrolled hypertension (with systolic BP greater than 160 mm/Hg or diastolic blood pressure greater than 95 mm/Hg), unstable angina, New York Heart Association grade II or greater congestive heart failure, cardiac arrhythmia requiring medication, clinically significant peripheral artery disease, grade II or greater peripheral vascular disease, myocardial infarction.
• 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), history of transient ischemic attack (TIA) within the past 6 months..
• Coagulopathy.
• Patients with unstable bone fractures that are not stress/weight bearing able.
• Patients with any other abnormality that would be scored as a grade 3 toxicity, except lymphopenia, direct manifestations of KS, direct manifestation of HIV, direct manifestation of HIV therapy, hyperbilirubinemia associated with protease inhibitors, asymptomatic hyperuricemia.
• Previous intravenous immunoglobulin (IVIG) or monoclonal antibody therapy within 30 days prior to enrollment.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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