Cell-Based Immunotherapy for Metastatic Melanoma
Name of the Trial
Phase II Study of Adoptive Transfer of Cloned Lymphocytes With Interleukin-2 After Cyclophosphamide and Fludarabine in Patients With Metastatic Melanoma (NCI-99-C-0158). See the protocol summary.
Dr. Steven Rosenberg, NCI Center for Cancer Research.
Why This Trial Is Important
The incidence of melanoma has risen significantly in recent decades, and the prognosis is poor for patients diagnosed with advanced, stage IV disease (cancer that has spread, or metastasized, to distant parts of the body). The five-year survival rate for these patients is less than 10 percent. No form of treatment currently available has been shown in randomized, controlled phase III trials to improve survival rates.
In this phase II trial, researchers are investigating a cell-based form of immunotherapy for stage IV melanoma that produced tumor shrinkage or disappearance in more than 50 percent of patients enrolled in an earlier part of the study. Immunotherapy involves harnessing immune-system components to treat or prevent disease.
Researchers will first harvest white blood cells (lymphocytes) from the patients' tumors. Next, the cancer-fighting potential of these tumor-infiltrating lymphocytes (TIL) will be further stimulated in the laboratory, and their numbers increased. The TIL will then be injected back into patients - a procedure known as adoptive transfer - after the patients have undergone preparatory chemotherapy to improve TIL survival. TIL injection will be accompanied by the administration of cytokines, proteins that stimulate immunological responses. Interleukin-2 and filgastrim are the cytokines used in this trial.
"This research demonstrates that cell-based immunotherapy can work," said Dr. Rosenberg.
Who Can Join This Trial
Researchers will enroll 200 patients aged 16 and over who have been diagnosed with metastatic melanoma resistant to standard therapy. See the list of eligibility criteria.
Study Site and Contact Information
The study is taking place at the NIH Clinical Center in Bethesda, Maryland. For more information, contact the NCI Surgery Branch directly at 301-402-4124 or 301-496-2132 or the NCI Clinical Studies Support Center at 1-888-NCI-1937 (toll free). The call is confidential.
Dudley ME, Wunderlich JR, Robbins PF, et al.: Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science 298 (5594): 850-4, 2002.[PUBMED Abstract]