This trial is evaluating whether Sargramostim will improve 1 primary outcome and 4 secondary outcomes in patients with Cancer of Skin. Measurement will happen over the course of Up to 90 days after the last study drug administration.
This trial requires 600 total participants across 2 different treatment groups
This trial involves 2 different treatments. Sargramostim is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.
"Treatment for metastatic melanoma consists of surgery, chemotherapy, targeted therapy, or a combination of these. Chemotherapy is often used to treat skin cancer but its utility against melanoma is debatable. Radiation therapy is used to treat tumors in the brain, eye, chest, or pelvis. The exact role of surgery in melanoma remains unclear." - Anonymous Online Contributor
"In the United States, it is estimated that 10,960 new cases of melanoma will be diagnosed, while 4,500 cases of melanoma will die in the year 2007 (3.0% of all cases) (National Cancer Institute (NCI)). The overall annual mortality rates for melanoma will nearly double in the next 2 decades, with more than 49,300 new cases and 37,600 melanoma deaths occurring annually by 2020 (3.7% of all cases). In 2007 there was an increase in the age-standardized crude death rates for melanoma from 3.1 per 100,000 for 1975 to 8.4 per 100,000 for 2005." - Anonymous Online Contributor
"A large proportion of melanomas are caused by UV light. In a large percentage, there may be genetic factors. The prevalence of melanoma varies with ethnicity and socioeconomic status." - Anonymous Online Contributor
"Mature and mature women are at a higher risk of naevus development, especially of uveal melanomas, whereas men older than 60 years suffer more frequently from melanomas of the scalp and neck and from naevi in the face. Moreover, in men, the risk of metastasis increases with the age. Mature and elderly women are at a higher risk for secondary melanomas, especially of nodular, infiltrating, and metastatic melanomas. These women, also, show a higher incidence of melanomas of the eyelid and nose." - Anonymous Online Contributor
"Based on our data on the prognosis of melanoma, the question of whether this disease can be treated and cured may seem very improbable. Whether the development of a clinically viable approach could be more problematic can be discussed later. In the meantime, we advise physicians and patients in whom these questions should be addressed, especially those with early-stage disease, to pursue research as thoroughly as possible in this area because we find that it is of high priority in patient care." - Anonymous Online Contributor
"Melanoma is a type of cancer involving the skin or underlying tissue, not the blood or lungs, that often appears coloured slightly or totally black. It most commonly forms skin changes such as a mole, itch, pigmentation or pain. It is usually first noticed on the hands or feet, on the lower part of the eyelid, or on the trunk or lower portion of the back. When the initial lesion has spread, it commonly spreads to the lymph nodes near the skin or on the lining of the eyes, nose or mouth, the brain or blood vessels. It most commonly kills skin lesions, spreads, and spreads to the lymph nodes. About 1 in 3 individuals with skin cancer will die from the disease." - Anonymous Online Contributor
"The overall survival rate varies from 1 year to 15 years. It varies according to melanoma type and also the individual patient. In terms of the age of the patient and the different clinical stages, it is very important for the melanoma patient to be monitored. They should have regular followups, get dermatology appointments and stay in contact with their doctor as often as possible. It makes a difference not just for the melanoma patient to go back and get another appointment every few months, but every few weeks. I am sending this email to remind you to go back regularly to your doctors and get regular appointments." - Anonymous Online Contributor
"Sargramostim showed no clinically relevant antitumor efficacy against MM xenografts or human MM cell xenografts in the EMMPRIN-deficient xenograft model. Data from a recent study suggest that the EMMPRIN-mediated sargramostim-induced activation of NF-κB is not involved in sargramostim-mediated antitumor efficacy against MM." - Anonymous Online Contributor
"Our patient's age significantly influences the survival of the patients with this cancer. It’s important to perform the appropriate treatment for patients who present with stage III and IV. However, we have to acknowledge the fact that in more favorable circumstances, the survival rates are far lower than the survival rate in patients presenting stage IV disease. The role of anti-VEGF and anti-angiogenic therapy in the treatment of melanoma is still a highly debated one. It’s important to monitor patients carefully to manage the side effects of this new method of treatment and to improve the outcome for patients who use it. Although, we have to note that, it’s important to do so." - Anonymous Online Contributor
"Sargramostim treatment has improved outcomes in melanoma patients, but in a small subgroup. Further research is recommended to identify the subgroup of patients who are most likely to benefit and to explore other immunomodulatory or immunostimulatory agents (such as immune-modulating cytokines or PD-1 and PD-L1 agonists, or PD-L1 inhibitors) when combined with chemotherapy or immunotherapy to improve outcome." - Anonymous Online Contributor
"In people with advanced melanoma on maintenance infusion of GM-CSF or G-CSF, sargramostim administered as a single intraportal infusion at a dose of 24 mg/m2 is a potentially safe procedure." - Anonymous Online Contributor
"Despite the lack of effectiveness, sargramostim can be safely administered to patients with melanoma because of its few side effects. Sargramostim improves quality of life in patients after surgery for melanoma and may increase cancer survival and/or prolong overall survival." - Anonymous Online Contributor