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Name of the Trial

Phase I Study of Sorafenib in Patients With Kaposi's Sarcoma (NCI-06-C-0083). See the protocol summary ³.

Principal Investigator

Dr. Robert Yarchoan, NCI Center for Cancer Research.

Dr. Robert Yarchoan Principal Investigator

Why This Trial Is Important

Kaposi's sarcoma (KS) is a type of cancer characterized by the abnormal growth of blood vessels and lesions in the skin and some internal parts of the body. KS is the most common cancer associated with acquired immunodeficiency syndrome (AIDS). There are several other forms of KS, including one (classic KS) that usually develops in elderly men of Mediterranean or Jewish descent and one (endemic KS) that occurs in Africa.

Because blood vessel growth is a central component of KS tumors, researchers believe that drugs targeting blood vessel growth may be effective in treating KS. In this trial, patients with either AIDS-related or non-AIDS-related KS will take varying doses of the drug sorafenib (Nexavar®) for up to 54 weeks. Sorafenib is a new type of targeted drug that blocks the activity of several proteins that are important for cell division and for the growth of new blood vessels (angiogenesis).

Researchers will examine the safety of the drug and determine how the drug is processed in patients with KS who are receiving antiretroviral therapy for human immunodeficiency virus (HIV) infection and in those who are not receiving such treatment. Certain protease inhibitors that are used to treat HIV can affect the metabolization of sorafenib.

"Sorafenib blocks several molecular pathways important for the growth of KS," said Dr. Yarchoan, "so we have a good rationale for using this FDA-approved drug [for kidney cancer] in patients with KS. Additionally, we are exploring the potential interactions between sorafenib and the antiretroviral drug ritonavir, which is often used to treat patients infected with HIV-1."

Who Can Join This Trial

Researchers seek to enroll 45 patients aged 18 or over with either AIDS-related or non-AIDS-related KS. See the list of eligibility criteria ⁴.

Study Site and Contact Information

This study is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

Glossary Terms

A disease caused by human immunodeficiency virus (HIV). People with acquired immunodeficiency syndrome are at an increased risk for developing certain cancers and for infections that usually occur only in individuals with a weak immune system. Also called AIDS.

Treatment with drugs that inhibit the ability of the human immunodeficiency virus (HIV) or other types of retroviruses to multiply in the body.

A compound that interferes with the ability of certain enzymes to break down proteins. Some protease inhibitors can keep a virus from making copies of itself (for example, AIDS virus protease inhibitors), and some can prevent cancer cells from spreading.

A drug used to treat advanced kidney cancer and a type of liver cancer that cannot be removed by surgery. It is also being studied in the treatment of other types of cancer. Sorafenib stops cells from dividing and may prevent the growth of new blood vessels that tumors need to grow. It is a type of kinase inhibitor and a type of antiangiogenesis agent. Also called BAY 43-9006, Nexavar, and sorafenib tosylate.