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The purpose of this study is to determine whether an outpatient combination of lovastatin and low-to-moderate dose interferon is effective in the treatment of patients with malignant melanoma.
Malignant melanoma, or simply melanoma, is a potentially fatal cancer which begins as a skin cancer and can spread very aggressively. The incidence of melanoma has been rising rapidly over the last decade and it is now becoming a serious health threat in young adults as well as older adults. Unfortunately, if melanoma escapes complete surgical removal, there are very few treatments which have been found very effective in controlling its growth and spread. If the cancer spreads to the lymph node system or beyond, the chances for long-term survival can be very poor.
This study proposes to test the effectiveness for melanoma treatment of a combination of two medicines which are in widespread use for other medical conditions. Interferon alfa-2b (also known simply as interferon or by a brand name Intron-A) is an exact replica of a protein produced by the human immune system. The human body makes this immune system regulator to help it kill cells in the body which are damaged or infected and thus need to be removed before they can cause further harm to the body. This medicine is often prescribed for infections like hepatitis, some types of cancer including melanoma, and immune system disorders. This study uses interferon in moderate doses, much less than typically used for melanoma treatment when it is used alone, and so the side effects of treatment may be milder. The other medicine being used in combination with it is lovastatin. This medicine is most often used to help patients reduce their cholesterol levels and therefore reduce the risk of heart attacks and strokes. Millions of people use this medicine because it has been found very safe and effective. Research has shown that it also has significant effects against the growth of cancer cells in laboratory cultures and in some animal models.
These two medicines have been used together to treat patients with cancer for several years in our medical practice, but until now they have not been formally tested in a clinical trial. This study will test how well the combination of these medicines can perform and test the hypothesis that they can achieve better survival and control of disease than currently available standard treatment. The incidence of side effects and other details will be monitored too.
This study is open to qualifying patients with stage 2, 3, or 4 melanoma. The results for patients in each group will be compared to other patients in the study with the same or similar stage of disease and with historical results of patients receiving the standard, already-approved treatments for similar stages of melanoma.
Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
lovastatin, interferon alfa-2b
Published on BioPortfolio: 2014-08-27T03:19:51-0400
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RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melan...
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving radiation t...
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor ...
Methylation of a CpG island (CGI; a dense cluster of CpGs) located in the 5' region of a gene suppresses transcription of that gene. Interferon regulatory factor 6 (IRF6) is associated with the expres...
To evaluate in vivo confocal microscopy (IVCM) findings of ocular surface squamous neoplasia (OSSN) during treatment with topical interferon alfa-2b (IFN alfa-2b).
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REP 2139 clears circulating hepatitis B virus (HBV) surface antigen (HBsAg), enhancing the restoration of functional control of HBV infection by immunotherapy. We assessed the safety and efficacy of R...
The congenital dyserythropoietic anemias (CDAs) are a group of rare inherited blood disorders characterized by ineffective erythropoiesis as the principal cause of anemia. We present a child with CDA ...
A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
There are three main types of skin cancer: basal cell carcinoma, squamous cell carcinoma and malignant melanoma. Basal cell carcinoma Basal cell carcinoma, or BCC, is a cancer of the basal cells at the bottom of the epidermis. It’s very common ...
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....