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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 3.
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Dr. Richard
Morgan
Protocol Chair |
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 age 18 and over who have metastatic
melanoma that has not responded to standard therapy. See
the list of eligibility criteria 4.
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.
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