New 'combination therapy' improves survival for malignant melanoma patients

PITTSBURGH, MAY 30 -- Researchers at the University of Pittsburgh Cancer Institute announced that an immunomodulating agent, histamine dihydrochloride (Maxamine), used in combination with lower doses of interleukin-2 (IL-2), improved survival for stage-IV malignant melanoma patients compared with those treated with the same doses of IL-2 alone. The Phase III, multi-center study included 305 patients with this most deadly and serious form of skin cancer, randomized to receive either the histamine/IL-2 combination or IL-2 alone. The results of the study will be presented for the first time at the Perspectives in Melanoma meeting in Pittsburgh, June 1-2.

The combination therapy improved overall survival, increased survival rates at 12, 18 and 24 months, and improved time-to-disease-progression over treatment with IL-2 alone. Improvement in survival was statistically significant in patients having metastases of their melanoma to the liver, a patient population that historically has had a very poor prognosis.

Preliminary results also indicated that treatment with histamine dihydrochloride and IL-2 was safe and well-tolerated and had substantially less toxicity than the high-dose regimens under which IL-2 was originally approved. The tolerability of the histamine/IL-2 combination therapy allowed these advanced-stage malignant melanoma patients to take this treatment at home.

"The patients in this study represented a group with factors that are indicative of a poor prognosis for survival, including liver metastases," explained Sanjiv S. Agarwala, M.D., lead-enrolling investigator for the study and associate medical director of the Melanoma Center at the University of Pittsburgh Cancer Institute. "This is the first well-controlled, multi-center Phase III trial to show a significant increase in survival among patients with advanced metastatic melanoma."

Treatment of Malignant Melanoma
Malignant melanoma is one of the most rapidly increasing cance

Contact: Heather Szafranski
University of Pittsburgh Medical Center

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