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 at
http://cancer.gov/clinicaltrials/NCI-99-C-0158.
Principal Investigator
Dr. Steven Rosenberg, NCI Center for Cancer Research
Why is This Trial 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 at
http://cancer.gov/clinicaltrials/NCI-99-C-0158#EntryCriteria_CDR0000067331.
Where Is This Trial Taking Place?
The study is taking place at the NIH Clinical Center in Bethesda, Md.
Contact Information
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.
An archive of "Featured Clinical Trial" columns is available at
http://cancer.gov/clinicaltrials/ft-all-featured-trials.
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