Study of Temzolomide and Gleevec in Advanced Melanoma

Study Overview
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Brief Summary
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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.

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

Conditions
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Melanoma, Advanced Melanoma

Intervention / Treatment
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* Drug: Gleevec
* Drug: Temodar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A:<br>Temozolomide plus imatinib | Drug: Gleevec<br>* Gleevec (600 mg) daily.<br>* Other names: Imatinib mesylate;Drug: Temodar<br>* Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.<br>* Other names: temozolomide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Grade 3 or 4 Adverse Events | Number of reported grade 3 or 4 adverse events | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | Response rate by RECIST | through study completion, an average of 1 year | 
| To Evaluate the Secondary Endpoints of Time to Disease Progression, Duration of Response, and Overall Survival of Patients Receiving Gleevec + Temozolomide |  | through study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Temzolomide, Gleevec, Melanoma, Advanced melanoma, Phase II