Growth factor blockade for treatment of Kaposi's sarcoma

Patient-volunteers are being recruited for a pilot clinical trial to test the experimental monoclonal humanized antibody bevacizumab in patients with Kaposi's sarcoma (KS). Bevacizumab binds to a protein called vascular endothelial growth factor (VEGF) that appears to be important in the growth of KS. VEGF promotes new blood vessel formation, and KS growth requires new blood vessel formation. Bevacizumab may block this process. This clinical trial involves the administration of bevacizumab to patients with KS indefinitely if there appears to be a benefit and very little toxicity. Patients are required to be off other therapies for KS for at least 3 weeks before entry.

Both HIV positive and HIV negative patients may be eligible for the trial. Patients who are HIV infected will also receive antiretroviral therapy if it is indicated. Those requiring antiretroviral therapy will be must have this optimized prior to beginning the experimental drug, bevacizumab. If patients are not already on antiretroviral therapy, this can be managed at NIH. Patients cannot have pulmonary or other life-threatening KS. The drug will be given by vein once every 3 weeks. Usually, it takes from 30 to 90 minutes to administer the bevacizumab. Patients will be observed for an effect of the bevacizumab on their KS and for evidence that the drug is causing the expected effect in the KS lesions. Therefore, as part of the protocol, tumor biopsies will be obtained from the skin on three separate occasions to look for biological effects on the tumor that may be caused by bevacizumab.

For more information, call the protocol office at (301)496-8959 or (800)243-2732, extension 4.