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Clinical Trial Results

Summaries of Newsworthy Clinical Trial Results

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    Posted: 02/22/2006
Related Pages
Search for Clinical Trials 1
NCI's PDQ® Cancer Clinical Trials Registry.

Melanoma Home Page 2
NCI's gateway for information about melanoma.
Response to Immunotherapy for Melanoma Tied to Autoimmunity

Reprinted from the NCI Cancer Bulletin, vol. 3/no. 8, Feb. 21, 2006 (see the current issue 3).

Patients treated for melanoma skin cancer with adjuvant interferon alfa-2b who developed clinical signs of autoimmunity were significantly more likely to respond to the treatment than patients who did not, a clinical trial has found. Autoimmunity occurs when the immune system begins to attack the body's own tissues.

Dr. Helen Gogas of the University of Athens Medical School, and colleagues enrolled 200 patients in a substudy of an ongoing trial. They prospectively evaluated the presence of autoantibodies and clinical manifestations of autoimmune disorders in melanoma patients who received adjuvant therapy with high-dose interferon alfa-2b.

The development of autoimmunity was associated with an approximate reduction by a factor of 50 in the risk of recurrence of melanoma. The benefit of interferon alfa-2b was primarily restricted to patients who showed signs of autoimmunity, the researchers report in the February 16, 2006, New England Journal of Medicine (see the journal abstract).

Efforts to identify biological markers for predicting which patients might respond have generally not been successful.

Although the new findings do not provide biological markers for patients who may have "immune-sensitive tumors," the results suggest a mechanistic connection between autoimmunity and the benefit from interferon alfa-2b in melanoma patients, says an accompanying editorial.

The study provides "the strongest data to date connecting the development of autoimmunity with a favorable antitumor effect of immunotherapy," write Drs. Henry Koon and Michael Atkins of Beth Israel Deaconess Medical Center.



Glossary Terms

adjuvant therapy (A-joo-vant THAYR-uh-pee)
Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.
biomarker (BY-oh-MAR-ker)
A biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Also called molecular marker and signature molecule.
clinical trial (KLIH-nih-kul TRY-ul)
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.
immunotherapy (IH-myoo-noh-THAYR-uh-pee)
Treatment to boost or restore the ability of the immune system to fight cancer, infections, and other diseases. Also used to lessen certain side effects that may be caused by some cancer treatments. Agents used in immunotherapy include monoclonal antibodies, growth factors, and vaccines. These agents may also have a direct antitumor effect. Also called biological response modifier therapy, biological therapy, biotherapy, and BRM therapy.
interferon (in-ter-FEER-on)
A biological response modifier (a substance that can improve the body's natural response to infections and other diseases). Interferons interfere with the division of cancer cells and can slow tumor growth. There are several types of interferons, including interferon-alpha, -beta, and -gamma. The body normally produces these substances. They are also made in the laboratory to treat cancer and other diseases.
prospective (proh-SPEK-tiv)
In medicine, a study or clinical trial in which participants are identified and then followed forward in time.


Table of Links

1http://www.cancer.gov/clinicaltrials/search
2http://www.cancer.gov/cancertopics/types/melanoma
3http://www.cancer.gov/ncicancerbulletin