Multi-Pronged Therapeutic Cancer Vaccine Regimen to be Studied in Melanom...(-CSF andinterferon-alpha-2b. About th...),Health

About the Clinical Trial

The randomized, open-label trial involves 120 participants at 23 centers across the United States and Canada. Stage IIIc, IVa and IVb melanoma patients with at least one measurable lesion and a life expectancy of at least six months will be included in the study. Participants will be randomized to one of two study groups. The first group will receive vaccine treatment consisting of a series of ALVAC and GM-CSF injections, followed by administration of interferon. The second group will receive administration of interferon alone.

The study is designed with the primary objective of progression-free survival (tumor stabilization) and the secondary objective of evaluation of safety, other efficacy endpoints (response rates), and the ability of the treatment regimen to induce an immune response.

The first cycle of vaccine treatment is conducted for a period of 16-weeks. If there is no evidence of disease progression during the first cycle, vaccine treatment is extended to a second 16 week cycle of treatment. In the study, patients in Group 2 whose disease has progressed during the first treatment cycle may be offered the vaccine regimen as the next cycle of treatment.

About Melanoma

Melanoma is the most serious form of skin cancer, accounting for 80 percent of all skin cancer deaths. Incidence and mortality rates for melanoma are rising faster than those for any other cancer. According to the American Cancer Society and Canadian Cancer Society, this year nearly 65,000 people in North America will be diagnosed with melanoma and more than 9,000 will die from the disease. By the year 2010, it is estimated that one in 50 people will have been diagnosed with melanoma. Standard treatments have minimal effect on survival, and sometimes cause significant toxicity.

About Therapeutic Cancer Vaccines

Therapeutic cancer vaccines represent an emerging, experimental type of
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