This phase 1 clinical trial recruiting in Buffalo, New York aims to evaluate the side effects and best dose of a vaccine therapy for patients with advanced (stage III/IV) melanoma that has spread from the skin to other parts of the body. The primary outcome to be investigated is the maximum tolerated dose (MTD) and treatment-related adverse events.
The details
In advanced melanoma (stage III/IV), cancer spreads from the skin to other parts of the body (metastasis). Immunotherapy (uses body’s own immune system to fight cancer) and targeted therapy (targets specific proteins) have shown significant treatment benefits in advanced melanoma. However, treatment-related adverse events are also common in these therapies.
Vaccines for melanoma are now being investigated as a promising treatment option. These vaccines are made of killed melanoma cells or parts of cells (antigens) which will stimulate the body’s immune system to destroy other melanoma cells in the body.
This trial will examine the recombinant human hsp110-gp100 chaperone complex vaccine. The main outcome measured will be the maximum dose before which toxicity (negative side effects) occurs. Toxicity is defined as severe or life-threatening adverse events.
Who are they looking for?
This study will recruit 20 patients aged 18 years or older with stage III/IV melanoma. Those who have brain metastasis should be previously treated with surgery and/or radiation, whichever is appropriate. Ideal candidates should have refused, been ineligible for, or failed at least one non-vaccine based therapy. All patients should be active, less than 50% time in bed, and should must have a life expectency of more than 6 months. Patients of child-bearing potential must agree to use acceptable contraceptive methods during treatment.
Patients cannot take part in this trial if they are pregnant or nursing. Patients should not have had an organ transplant or be taking high doses of steroids. Patients with rheumatoid arthritis, vitiligo (loss of skin color), inflammatory bowel disease, Grave’s disease (over production of thyroid hormone), multiple sclerosis (disease of nervous system), history of allergic reactions and uncontrolled infections, among others, are excluded from this study. Patients should not have received a treatment within 30 days prior to enrollment.
How will it work
Patients will receive the vaccine on days 1, 15, and 43, unless unacceptable side effects are present. The total time of this study is 6 months.
