This trial is evaluating whether SIR-Spheres® Yttrium 90 will improve 1 primary outcome and 4 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 5 years.
This trial requires 26 total participants across 2 different treatment groups
This trial involves 2 different treatments. SIR-Spheres® Yttrium 90 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.
Currently, there is no cure for melanoma, but there are several effective treatments that have shown significant success. Some of these treatments are still used today, and may not have been used 10 years ago. The best way to manage melanoma is to stay in your dermatologist’s office in a timely fashion and never let melanoma progress to a more dangerous stage. If melanoma progresses to the point of needing therapy, dermatologists are equipped to treat skin cancer and help patients find a treatment strategy that suits their specific needs. Melanoma can be very painful, and patients should see a dermatologist immediately upon being diagnosed to obtain treatment.
Melanoma is treated with a variety of therapies. A combination of topical and oral aminolevulinic acid combined with systemic therapy for the purpose of melanoma eradication could be an exciting treatment option for this malignancy.
Melanoma, which is a tumor originating from a melanocyte, causes the creation of melanin, a substance which helps to form shades within the skin, and melanogenesis, which creates a dark pigment that allows us to have color vision and to absorb wavelengths of light. Melanomas and melanocytes are usually found near the edges of the skin, or a pigmented streak around a mole, nipple or scar. Although not all [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) is a melanoma, the two are related. Treatment of melanoma is often done by removal, which removes or destroys the tumor. It is rare for cancer to start as a mole. There are many types of melanoma, including a type called lentigo maligna.
It has been concluded that early symptoms of melanoma include loss of appetite, swelling of the lymph nodes or pain, an irregular or enlarging growth, and itchiness. If the lesion does not have these symptoms, it is usually benign. It may be useful to have an examination by a physician as well as examining the lesion.
Melanoma develops because cells that normally live in the skin begin developing cells that no longer live in the skin. Over time, those cells undergo mutations in the genes on their chromosomes that cause changes in their appearance. Some of these changes happen early on. Melanomas may be prevented in about 80 percent of cases by early removal of sundamaged skin.
The presence of family history of melanoma does not provide additional information to the risk for development of melanoma and may lead to undertreatment in this group of patients. It may influence the decision to have preventive measures such as surveillance or intervention.
Sir-spheres® yttrium 90 used in combination with surgery and regional chemotherapy in the treatment of metastatic melanoma is a safe tool which achieves long-term survival.
The findings indicate that use of yttrium 90 sir-spheres is generally safe for patients with unresectable metastatic disease. The safety profile of SIR-SPY is in a similar manner to that seen with other treatments for secondary bone metastases, namely, p53-directed treatment with radionuclides, radiation therapy and bisphosphonates.
Melanoma is the fifth leading cause of death in cancer patients, but it accounts for only 0.1-0.2% of all cancer cases in the United States. The U.S. mortality ratio for melanoma is decreasing. Melanoma is difficult to diagnose early in its progress, and when it is finally diagnosed, it often has an advanced stage. The 5-year survival rate for melanoma is 77%; however, this rate drops even further to 40% in those with nodular melanoma or more than 2 mm thick.
It seems that sir-spheres® yttrium 90, an alpha-particle emitting isotope, demonstrates an increase in tumour regressiveness of tumors of various histological stages, but does not appear to be more effective than a placebo in terms of improving the long-term quality of life of patients with melanoma.
SIR-spheres® Yttrium 90 has shown an antitumor activity, comparable to that of radiotherapy. SIR-spheres® Yttrium 90 showed an antitumor activity comparable to that of the combined therapy of 5-FU and CTX in mice with hepatocellular carcinoma.