Last updated on October 2005

PS-341 With Oral Temozolomide in Patients With Advanced Refractory Solid Tumors or Melanoma


Brief description of study

Patients are asked to participate in this research because they have been diagnosed as having cancer that is not curable by any standard means including surgery or radiation therapy or other treatments. The natural history of the patient’s cancer is that the disease will continue to spread and will cause a loss of health and eventually death. This study will examine if two drugs Temozolomide and PS-341 can be combined and given to patients without severe side effects. We will try to determine a dose of each medication that is safe and can make the patient’s tumor change in a way to make it more sensitive to chemotherapy such as Temozolomide. Our ultimate goal is to find treatment that may be effective in treating malignant melanoma. However in the initial part of the trial, patients with other cancers will also be allowed to go on treatment. Temozolomide has been FDA approved for brain tumors and shown to be effective in melanoma similar to another drug (DTIC) that is approved for melanoma. PS-341 is an investigational agent that has been given to many patients in early trials, but its ability to shrink cancers such as melanoma is unknown. It is a new form of cancer therapy that works by blocking the activity of proteasomes. Proteasomes are found in all cells including cancer cells. By blocking them we may make the cancer cell especially sensitive to chemotherapy and death. We have reason based on test tube studies and animal experiments to believe that this combination of Temozolomide and PS-341 may be especially effective in melanoma and we will test that in the later part of the trial after the correct doses are defined. In the last phase of the study between 30 and 75 patients with melanoma will be given the combination of treatments to assess how effective it is at controlling or shrinking melanoma and how severe the side effects are on the rest of the body. This treatment is considered investigational for melanoma.

Clinical Study Identifier: NCT00209248

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Jeff Sosman, MD

Vanderbilt-Ingram Cancer Center
Nashville, TN United States
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