A Phase I/II Study of Daily Oral Dosing With Temozolomide and Sunitinib Malate for 6 Weeks of an 8-Week Cycle in Patients With Metastatic and Unresectable Locally-Advanced Malignant Melanoma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of the maximum tolerated dose (MTD) and overall safety of sunitinib malate when administered concomitantly with temozolomide in patients with advanced malignant melanoma.
3 months
Yes
Bartosz Chmielowski, MD, PhD
Principal Investigator
University of California, Los Angeles
United States: Institutional Review Board
P05513-GA6181FZ
NCT00859326
April 2009
April 2012
Name | Location |
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University of California Los Angeles | Los Angeles, California 90095-6951 |