This phase 2 trial aims to measure the immune system response to a vaccine to treat melanoma. The main outcome of this trial will be to determine the effectiveness of treatment with vaccine therapy in stage 3 or 4 melanoma patients.
The details
Immunotherapies stimulate the immune system to fight cancer cells the way it would a virus or bacteria. Previously the same immunotherapies have been used to treat melanoma patients. However, a more personalized immunotherapy, one created from the cancer cells of an individual patient, may be more effective.
The current trial will examine the effectiveness of a personalized melanoma vaccine. The main outcomes to be measured are the tumor response to the vaccine and the time to recurrence (when the cancer comes back).
Who are they looking for?
This trial will recruit 120 stage 3 or 4 melanoma patients. All participants must have tumors that can be surgically removed, and must be considered disease free after surgery. Participants may have had chemotherapy, radiotherapy or biologic therapy but vaccination will not begin until this therapy is finished. Participants must have normal blood values. Participants must not have immune deficiency disease and must not be being treated with therapies that suppress (block) the immune system. Participants must not be pregnant or breastfeeding and must not have an active pulmonary disease.
How will it work
Enrolled patients will have surgery to remove the tumor and blood samples will be taken to prepare the vaccine. Following any chemotherapy or radiation treatments, the patients will be randomized to receive the active vaccine or the inactive vaccine (a placebo, a substance with no effect on the body). Patients will be injected once a month for 3 months, followed by boosters at 6, 12 and 18 months. Patients will be then followed for 2 years. Disease-free survival (time from treatment to recurrence) will be measured.
