Trial Information

Phase 2 Study of Interferon Alfa-2b and Lovastatin Combination Therapy for Patients With High-risk Resected or Unresectable Malignant Melanoma

Malignant melanoma, or simply melanoma, is a potentially fatal cancer which begins as a skin
cancer and can spread very aggressively. The incidence of melanoma has been rising rapidly
over the last decade and it is now becoming a serious health threat in young adults as well
as older adults. Unfortunately, if melanoma escapes complete surgical removal, there are
very few treatments which have been found very effective in controlling its growth and
spread. If the cancer spreads to the lymph node system or beyond, the chances for long-term
survival can be very poor.

This study proposes to test the effectiveness for melanoma treatment of a combination of two
medicines which are in widespread use for other medical conditions. Interferon alfa-2b
(also known simply as interferon or by a brand name Intron-A) is an exact replica of a
protein produced by the human immune system. The human body makes this immune system
regulator to help it kill cells in the body which are damaged or infected and thus need to
be removed before they can cause further harm to the body. This medicine is often
prescribed for infections like hepatitis, some types of cancer including melanoma, and
immune system disorders. This study uses interferon in moderate doses, much less than
typically used for melanoma treatment when it is used alone, and so the side effects of
treatment may be milder. The other medicine being used in combination with it is
lovastatin. This medicine is most often used to help patients reduce their cholesterol
levels and therefore reduce the risk of heart attacks and strokes. Millions of people use
this medicine because it has been found very safe and effective. Research has shown that it
also has significant effects against the growth of cancer cells in laboratory cultures and
in some animal models.

These two medicines have been used together to treat patients with cancer for several years
in our medical practice, but until now they have not been formally tested in a clinical
trial. This study will test how well the combination of these medicines can perform and
test the hypothesis that they can achieve better survival and control of disease than
currently available standard treatment. The incidence of side effects and other details
will be monitored too.

This study is open to qualifying patients with stage 2, 3, or 4 melanoma. The results for
patients in each group will be compared to other patients in the study with the same or
similar stage of disease and with historical results of patients receiving the standard,
already-approved treatments for similar stages of melanoma.