Immunotherapy for Patients
with Metastatic Melanoma
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.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.
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