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 at http://cancer.gov/clinicaltrials/NCI-07-C-0003.

Principal Investigator
Dr. Steven A. Rosenberg, NCI CCR

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 at http://cancer.gov/clinicaltrials/NCI-07-C-0003.

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.