Name of the Trial
Phase I/II Study of Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes After Cyclophosphamide and Fludarabine in Patients With Metastatic Melanoma (NCI-03-C-0162). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-03-C-0162.

Principal Investigators
Dr. Richard A. Morgan (protocol chair) and Dr. Steven A. Rosenberg, NCI Center for Cancer Research

Why Is This Trial Important?
Melanoma is cancer that forms in the melanocytes, cells that give skin its color. The prognosis for patients with melanoma that has spread to other parts of the body (metastasized) is poor.

Immunotherapy is treatment that stimulates the immune system's ability to fight disease. In one type of immunotherapy, patients are given tumor-infiltrating lymphocytes (TIL), disease-fighting white blood cells harvested from the patients' own tumors. The TIL are grown in the laboratory to increase their numbers and then injected back into the patients. Treatment with TIL, however, requires administration of interleukin 2 (IL-2) at the same time. IL-2 is a protein that helps TIL survive in the body, but has significant side effects when given by injection. In this trial, TIL that have been modified to make IL-2 are given to patients with metastatic melanoma after the patients have been treated with chemotherapy to reduce the number of existing white blood cells and make space for the incoming TIL cells.

"For TIL to be successful, patients must receive IL-2 and, consequently, treatment has to be discontinued after a few days because of IL-2-related toxicity," said Dr. Morgan. "The challenge is to figure out how to give this potentially very beneficial treatment without concurrent IL-2 administration. Our solution is to genetically engineer TIL to produce its own IL-2. This should allow TIL to survive long enough in the body to produce a therapeutic effect without subjecting patients to the toxicity of intravenous IL-2."

Who Can Join This Trial?
Researchers seek to enroll 132 patients aged 18 and over who have metastatic melanoma that has not responded to standard therapy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-03-C-0162.

Where Is This Trial Taking Place?
The study will be conducted at the NIH Clinical Center in Bethesda, Md.

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