Everolimus in Treating Patients With Stage IV Melanoma
RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma|
- Proportion of patients with progression-free disease at 16 weeks [ Designated as safety issue: No ]
- Median overall survival [ Designated as safety issue: No ]
- Tumor response rate for 2 consecutive evaluations at least 8 weeks apart [ Designated as safety issue: No ]
- Toxicity as measured by CTCAE v. 3.0 [ Designated as safety issue: Yes ]
- Efficacy as measured by fludeoxyglucose F 18 uptake at baseline and at weeks 8 and 16 by positron-emission tomography imaging [ Designated as safety issue: No ]
- Efficacy as measured by the intensity of tissue vascular endothelial growth factor (VEGF) based on percentage of tumor cells positive for stain and the intensity of staining and microvessel density at 8 weeks and at diseae progression [ Designated as safety issue: No ]
- Efficacy as measured by serum VEGF levels at baseline, 8 weeks, and at disease progression [ Designated as safety issue: No ]
- Effect of therapy on the immune system at 8 weeks [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.
- Determine the median overall survival of patients treated with this drug.
- Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.
PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.
Show 94 Study Locations
|Study Chair:||Ravi D. Rao, MD, MBBS||Mayo Clinic|
|Investigator:||Harold E. Windschitl, MD||Coborn Cancer Center|
|Investigator:||William J. Maples, MD||Mayo Clinic|
|Investigator:||Michael K. Gornet, MD||Mayo Clinic|
|Investigator:||James N. Ingle, MD||Mayo Clinic|
|Investigator:||Edward T. Creagan, MD||Mayo Clinic|
|Investigator:||Judith S. Kaur, MD||Mayo Clinic|
|Investigator:||Barbara A. Pockaj, MD||Mayo Clinic Hospital|
|Investigator:||Evanthia Galanis, MD||Mayo Clinic|
|Investigator:||Charles L. Loprinzi, MD||Mayo Clinic|
|Investigator:||Henry C. Pitot, MD||Mayo Clinic|
|Investigator:||Lori A. Erickson, MD||Mayo Clinic|
|Investigator:||Val J. Lowe, MD||Mayo Clinic|