Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma
OBJECTIVES:
Primary
- Determine the median time to disease progression in patients with stage IV malignant
melanoma treated with everolimus.
Secondary
- 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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with progression-free disease at 16 weeks
No
Ravi D. Rao, MD, MBBS
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000402871
NCT00098553
April 2005
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview Southdale Hospital | Edina, Minnesota 55435 |
Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
MeritCare Broadway | Fargo, North Dakota 58122 |
CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Hinsdale, Illinois 60521 | |
John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
Southwest Medical Center | Liberal, Kansas 67901 |
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
Trinity Medical Center - East | Moline, Illinois 61265 |
Bettendorf, Iowa 52722 | |
John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Mercy Capitol Hospital | Des Moines, Iowa 50307 |
Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
Alexandria, Minnesota 56308 | |
MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
Brainerd Medical Center | Brainerd, Minnesota 56401 |
St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
St. Joseph's Hospital | St Paul, Minnesota 55102 |
Adult and Pediatric Urology, P.L.L.P. | St. Cloud, Minnesota 56303 |
McFarland Clinic, PC | Ames, Iowa 50010 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Mid Dakota Clinic, PC | Bismarck, North Dakota 58501 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Woodwinds Health Campus | Woodbury, Minnesota 55125 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
Franciscan Skemp Healthcare - La Crosse Campus | La Crosse, Wisconsin 54601 |
Medcenter One Hospital Cancer Care Center | Bismarck, North Dakota 58501 |
St. Alexius Medical Center Cancer Center | Bismarck, North Dakota 58502 |