Temozolomide and Everolimus in Treating Patients With Stage IV Melanoma That Cannot be Removed by Surgery
- Registration Number
- NCT00521001
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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. Everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Giving everolimus together with temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery
- Detailed Description
OBJECTIVES:
Primary
* Estimate the 9-week progression-free survival rate for patients with stage IV malignant melanoma treated with everolimus and temozolomide.
Secondary
* Evaluate overall survival time.
* Evaluate time to disease progression.
* Evaluate confirmed response rate.
OUTLINE: This is a multicenter study.
Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
All patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for relative numbers of T, B, and NK cells via flow cytometry, quantitative immunoglobulin levels (IgG, IgM, and IgA), Tetramer/ELISPOT CTL frequencies to CMV/EBV immunodominant antigens, V beta T cell spectratyping, and VEGF levels via ELISA.
After completion of study treatment, patients are followed every 8 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description everolimus + temozolomide everolimus Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for relative numbers of T, B, and NK cells via flow cytometry, quantitative immunoglobulin levels (IgG, IgM, and IgA), Tetramer/ELISPOT CTL frequencies to CMV/EBV immunodominant antigens, V beta T cell spectratyping, and VEGF levels via ELISA. After completion of study treatment, patients are followed every 8 weeks. everolimus + temozolomide temozolomide Patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, 22-26, and 29-33 and oral temozolomide once a day on days 8-12 for course 1 only. For course 2 and all subsequent courses, patients receive oral everolimus once a day on days 1-5, 8-12, 15-19, and 22-26 and oral temozolomide once a day on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. All patients undergo blood sample collection periodically for correlative studies. Samples are analyzed for relative numbers of T, B, and NK cells via flow cytometry, quantitative immunoglobulin levels (IgG, IgM, and IgA), Tetramer/ELISPOT CTL frequencies to CMV/EBV immunodominant antigens, V beta T cell spectratyping, and VEGF levels via ELISA. After completion of study treatment, patients are followed every 8 weeks.
- Primary Outcome Measures
Name Time Method 9-week Progression-free Survival Rate at 9 weeks The primary endpoint of this trial is the 9 week PFS rate. A patient is a success if they are progression free at their cycle 2 evaluation (approximately 9 weeks post registration). All patients, who meet the eligibility criteria, sign a consent form, and start treatment will be included in the evaluation of the 9-week PFS rate (evaluable patients). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. If some patients are lost to follow up prior to their cycle 2 evaluation, the Kaplan-Meier method will be used to estimate the 9 week PFS rate. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Secondary Outcome Measures
Name Time Method Survival Time Time from registration to death due to any cause; Up to 5 years Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time to Disease Progression Time from registration to the earliest date documentation of disease progression; Up to 5 years Time to disease progression is defined as the time from registration to the earliest date documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time to progression will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Confirmed Response Rate (Complete Response and Partial Response) Up to 5 years Confirmed response rates will be evaluated by dividing the number of confirmed responders (i.e. patients that achieve a CR or PR on consecutive evaluations) by the total number of evaluable patients. Confidence intervals for the true response rate will be calculated using the properties of the binomial distribution.
Trial Locations
- Locations (195)
Meeker County Memorial Hospital
🇺🇸Litchfield, Minnesota, United States
St. Mary - Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸Saint Cloud, Minnesota, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Park Nicollet Cancer Center
🇺🇸Saint Louis Park, Minnesota, United States
HealthEast Cancer Care at Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
Medcenter One Hospital Cancer Care Center
🇺🇸Bismarck, North Dakota, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
North Suburban Medical Center
🇺🇸Thornton, Colorado, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸Saint Joseph, Michigan, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Duluth Clinic Cancer Center - Duluth
🇺🇸Duluth, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
🇺🇸Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
St. Alexius Medical Center Cancer Center
🇺🇸Bismarck, North Dakota, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
HealthEast Cancer Care at St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
St. Francis Cancer Center at St. Francis Medical Center
🇺🇸Shakopee, Minnesota, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
🇺🇸Bismarck, North Dakota, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
MeritCare Broadway
🇺🇸Fargo, North Dakota, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Mercy Medical Center
🇺🇸Springfield, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
MeritCare Bemidji
🇺🇸Bemidji, Minnesota, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program
🇺🇸Denver, Colorado, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Miller - Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸Ottumwa, Iowa, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Minnesota Oncology Hematology, PA - Maplewood
🇺🇸Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States