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Name of the Trial

Phase II Study of Nonmyeloablative Lymphodepleting Chemotherapy Comprising Cyclophosphamide and Fludarabine Phosphate Followed By Anti-p53 T-Cell Receptor-Transduced Peripheral Blood Lymphocytes and High-Dose Aldesleukin in Patients With Metastatic Cancer That Overexpresses p53 (NCI-07-C-0003). See the protocol summary ².

Principal Investigator

Dr. Steven A. Rosenberg, NCI Center for Cancer Research.

Dr. Steven Rosenberg Principal Investigator

Why This Trial Is Important

The p53 gene is mutated or deleted (lost) in more than 50 percent of all human cancers. Mutation of this gene often leads to the accumulation of mutant p53 protein inside cells. This abnormal accumulation or "overexpression" of p53 protein occurs because mutant p53 protein is not as easily degraded by cells as normal p53 protein. NCI scientists are now recruiting patients for a clinical trial of a new treatment that targets this common characteristic of cancer cells.

In the trial, researchers will harvest normal T lymphocytes from patients' blood and modify these immune system cells to recognize p53 protein. The modified cells will be enriched in the laboratory and then infused back into the patients. The modified cells will be stimulated further inside the body with interleukin-2 (IL-2 or aldesleukin), an immune system hormone that may also help the cells survive longer.

"We have demonstrated that gene-modified T cells can recognize and kill melanoma cells overexpressing a specific antigen, leading to a clinical response in some patients," said Dr. Rosenberg. "With this trial, we hope to extend this type of immunotherapy to patients with more common cancers."

Patients in this trial will be separated into two treatment groups. Patients with melanoma and renal cell cancer, diseases that respond to IL-2 therapy, will form one group, and those with other types of metastatic cancer will form the other group.

Who Can Join This Trial

Researchers seek to enroll 82 patients aged 18 or over with metastatic cancer that tests positive for p53 overexpression and has progressed despite standard treatment. See the list of eligibility criteria ³.

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 Studies Support Center (CSSC) at 1-888-NCI-1937. The call is toll free and confidential.

Glossary Terms

Any substance that causes the body to make a specific immune response.

The complex group of organs and cells that defends the body against infections and other diseases.

Treatment to boost or restore the ability of the immune system to fight cancer, infections, and other diseases. Also used to lessen certain side effects that may be caused by some cancer treatments. Agents used in immunotherapy include monoclonal antibodies, growth factors, and vaccines. These agents may also have a direct antitumor effect. Also called biological response modifier therapy, biological therapy, biotherapy, and BRM therapy.

One of a group of related proteins made by leukocytes (white blood cells) and other cells in the body. Interleukin-2 is made by a type of T lymphocyte. It increases the growth and activity of other T lymphocytes and B lymphocytes, and affects the development of the immune system. Aldesleukin (interleukin-2 made in the laboratory) is being used as a biological response modifier to boost the immune system in cancer therapy. Interleukin-2 is a type of cytokine. Also called IL-2.

A tumor suppressor gene that normally inhibits the growth of tumors. This gene is altered in many types of cancer.

A molecule made up of amino acids that are needed for the body to function properly. Proteins are the basis of body structures such as skin and hair and of substances such as enzymes, cytokines, and antibodies.