Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.
Drug: sunitinib malate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Overall safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Response rate as assessed by modified RECIST criteria (phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Response rate as assessed by modified RECIST criteria (Phase I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: sunitinib malate, temozolomide||Drug: sunitinib malate Drug: temozolomide|
- Assess the maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I)
- Assess the overall safety of this regimen in these patients. (Phase I)
- Determine the response rate in patients treated with this regimen. (Phase II)
- Determine the response rate in patients treated with this regimen. (Phase I)
- Determine the safety and tolerability of this regimen in these patients. (Phase II)
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II study.
Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days 1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up very 6 months for up to 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005472
|United States, California|
|University of California Los Angeles (UCLA)|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Bartosz Chmielowski, MD||University of California, Los Angeles|