Study of Temzolomide and Gleevec in Advanced Melanoma

Phase I/II Study of Temozolomide and Gleevec (Imatinib Mesylate, Formerly Known as STI571) in Advanced Melanoma

This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.

Inclusion Criteria:

• Histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
• Prior chemotherapy, immunotherapy, radiation therapy (Phase I portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide
• Measurable disease
• Performance status <= 2
• Life expectancy greater than 3 months

Exclusion Criteria:

• No prior treatment with temozolomide or imatinib mesylate
• Organ allografts
• Prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area
• Pregnancy or lactation
• History of second cancer
• Known hypersensitivity to temozolomide or imatinib
• Use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment