Combination of Temozolomide and Sunitinib in Treatment of Patients With Metastatic and Unresectable Malignant Melanoma
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- STATUS
- Recruiting
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- participants needed
- 42
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- sponsor
- University of California, Los Angeles
Summary
The purpose of this study is to determine the safety and efficacy of the treatment with a combination of chemotherapy drug, temozolomide with a drug-blocking blood vessel formation, sunitinib malate in patients with advanced melanoma..
Description
The therapy with a combination of a chemotherapeutic agent with a known activity against melanoma (temozolomide) and a new small molecule that inhibits angiogenesis (sunitinib malate) will be tested in this clinical trial. Both agents have been approved for use in humans with different types of malignancies, and the tolerated doses of each medication have been established,but they have never been studied in combination. Therefore, this trial will start as a phase-1 trial that will allow us to establish the maximum tolerated dose of both medications, and then we will proceed with the phase-2 trial. Temozolomide has been widely used in patients with melanoma, and protracted dosing of the drug has been shown to be safe; sunitinib malate has not been studied in melanoma. We will use temozolomide at a dose of 75mg/m2 daily, and only the dose of sunitinib malate will be escalated. The patient will be started on 12.5 mg of sunitinib malate daily. Both drugs will be given daily for 6 weeks out of an 8-week cycle. If no dose limiting toxicities are noted, the dose of sunitinib malate will be increased to 25 mg daily, and then to 37.5 mg daily.
Details
| Condition | Melanoma |
|---|---|
| Treatment | Temozolomide, Sunitinib |
| Clinical Study Identifier | NCT00859326 |
| Sponsor | University of California, Los Angeles |
| Last Modified on | 7 November 2020 |
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