Name of the Trial
Phase I Study of Lymphodepleting Chemotherapy Comprising Cyclophosphamide and Fludarabine Followed by MART-1 Antigen Vaccination, Transduced Autologous Tumor-Infiltrating Lymphocytes or Peripheral Blood Lymphocytes, and High-Dose Interleukin-2 in Patients with HLA-A*0201-Positive Metastatic Melanoma. See the protocol summary at http://cancer.gov/clinicaltrials/NCI-04-C-0251.

Principal Investigator
Dr. Steven Rosenberg, NCI Center for Cancer Research

Why This Trial Is Important
Clinical trials involving an immunotherapy method known as adoptive cell transfer have shown promising results in some patients with melanoma that has metastasized (spread) to other parts of the body.

In adoptive cell transfer, tumor-infiltrating T lymphocytes, or TILs, are harvested from a patient's tumor(s), and the cancer-fighting properties of these cells are enhanced in the laboratory. The TILs are subsequently expanded (grown) to increase their numbers and then injected back into the patient. Adoptive cell transfer for melanoma focuses on TILs that target an antigen called MART-1, which is found on melanoma cells.

Tumor-reactive TILs cannot be obtained, however, from many patients. Thus, researchers have developed techniques to genetically engineer a patient's T lymphocytes to express the receptor protein that recognizes and binds to MART-1. The modified cells are then grown and infused into the patient.

This study will involve two groups of patients. One group will receive TILs containing transferred genes for the MART-1 receptor; the second group will receive T lymphocytes isolated from blood that also contain added MART-1 receptor genes.

"If these genetically engineered cells prove safe and show antitumor activity," said Dr.Rosenberg, "we plan to create lymphocytes that can target more common malignancies, including breast and colorectal cancers. There is tremendous potential here."

Who Can Join This Trial
Researchers will enroll 80 patients aged 18 and over who have been diagnosed with metastatic melanoma. See the complete list of eligibility criteria at http://www.cancer.gov/clinicaltrials/NCI-04-C-0251#EntryCriteria_CDR0000383246.

Study Site and Contact Information
The trial is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.