Name of the Trial
Phase I/II Study of Nelfinavir Mesylate in Patients with Recurrent, Metastatic, or Unresectable Liposarcoma (CHNMC-04090). See the protocol summary at http://cancer.gov/clinicaltrials/CHNMC-04090.

Principal Investigator
Dr. Warren Chow, City of Hope Comprehensive Cancer Center

Why This Trial Is Important
Liposarcoma is a malignant tumor that develops in fat tissue. It is one of the most common types of soft tissue sarcoma in adults. Although surgery and radiotherapy may be used successfully to treat localized tumors, treatment of advanced liposarcoma rarely results in a cure.

Nelfinavir, a drug used in the treatment of human immunodeficiency virus (HIV) infection, may be able to help stop the growth of liposarcoma. Nelfinavir is a protease inhibitor, a type of drug that interferes with the ability of certain enzymes (proteases) to break down proteins, which is a process that is necessary for some cells and viruses to reproduce.

In HIV-infected patients, nelfinavir often interferes with the growth of fat cells. This characteristic led researchers to test the drug on liposarcoma cells in the laboratory. The research showed that nelfinavir slowed the growth of liposarcoma cells and caused them to undergo apoptosis (programmed cell death).

In this trial, researchers will test nelfinavir in patients with advanced liposarcoma to see if it helps shrink their tumors. They will also seek to establish the drug's maximum tolerated dose and its pharmacokinetics (fate of the drug in the body) in these patients.

"Currently, we don't have very many options available to treat liposarcoma that recurs or metastasizes," said Dr. Chow. "We need to develop a new therapy that targets the key molecular pathways of this cancer. Nelfinavir is a drug that is already FDA approved and has shown promise in laboratory tests, and so we hope to see evidence of clinical activity in this trial."

Who Can Join This Trial
Researchers will enroll 40 patients with confirmed diagnoses of recurrent, metastatic, or unresectable liposarcoma. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/CHNMC-04090.

Study Site and Contact Information
This trial is taking place at the City of Hope Comprehensive Cancer Center in Duarte, CA. For more information, call the City of Hope's Clinical Trials Office toll free at 1-800-826-4673 or e-mail becomingapatient@coh.org.