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Temozolomide and Everolimus in Treating Patients With Stage IV Melanoma That Cannot be Removed by Surgery
This study is ongoing, but not recruiting participants.
First Received: August 24, 2007   Last Updated: April 14, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00521001
  Purpose

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


Condition Intervention Phase
Melanoma (Skin)
Drug: everolimus
Drug: temozolomide
Genetic: reverse transcriptase-polymerase chain reaction
Other: flow cytometry
Other: immunohistochemistry staining method
Other: immunologic technique
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Temozolomide and Everolimus (RAD001) Therapy for Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 9-week progression-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Confirmed response rate (complete response and partial response) [ Designated as safety issue: No ]
  • Microvascular density and VEGF expression as assessed by IHC [ Designated as safety issue: No ]
  • Plasma VEGF levels at baseline, 9 weeks, and at progression [ Designated as safety issue: No ]
  • Immunologic parameters [ Designated as safety issue: No ]
  • MGMT (O-6-methylguanine-DNA methyltransferase) [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: January 2008
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.
  • Assess the toxicity profile of the combination of everolimus and temozolomide in patients with stage IV malignant melanoma.
  • Assess the clinical benefit rate (i.e., stable disease, partial remission, and complete response rates).
  • Describe the impact of therapy on parameters of angiogenesis and immunity (systemic and tumor microenvironment).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma with manifestations of metastatic disease.
  • Unresectable stage IV malignant melanoma with measurable disease

    • Measurable disease defined as at least one lesion with the longest diameter measured as ≥ 20 mm by CT scan or MRI scan OR ≥ 10 mm by spiral CT
  • No previously untreated or unstable active brain metastases within the past 3 months
  • No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • ANC ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Hemoglobin ≥ 9.0 g/dL
  • Alkaline phosphatase ≤ 3 times institutional upper limit of normal (ULN)
  • Creatinine ≤ 1.5 times ULN
  • AST ≤ 3 times ULN
  • INR ≤ 1.5
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients and their partners must use effective contraception
  • Able to return to a NCCTG institution for follow-up
  • Able to forego foods high in fat content 2 hours prior to and 2 hours after administration of everolimus therapy
  • Able to provide blood samples for research purposes
  • No hypersensitivity to temozolomide, dacarbazine, or any analog of sirolimus
  • No history of malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only
  • No immunosuppression from any cause, including known HIV infection or chronic immunosuppressive therapy
  • No impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome)
  • No serious medical condition that may make it unsafe for a patient to enroll in study, including any of the following:

    • Severely impaired lung function (FEV1 < 1 liter), unstable angina pectoris (ongoing symptoms), ongoing symptomatic congestive heart failure (i.e., NYHA class I-IV) refractory to appropriate therapy, or myocardial infarction within the past 6 months, or serious uncontrolled cardiac arrhythmia
    • Uncontrolled diabetes in spite of optimal therapy (i.e., a history of fasting serum glucose > 150 mg/dL)
    • Any active (acute or chronic) or uncontrolled infection/disorders
    • Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the study treatment
    • Liver disease (i.e., uncompensated cirrhosis or active hepatitis with elevated liver enzymes)
  • No bleeding diathesis
  • No concurrent severe condition that would make it undesirable for the patient to participate in this trial or that would jeopardize compliance with the trial

PRIOR CONCURRENT THERAPY:

  • Must have recovered from effects of prior antineoplastic therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas)
  • At least 4 weeks since prior immunotherapy
  • At least 4 weeks since prior biologic therapy
  • At least 4 weeks since prior radiosurgery
  • At least 4 weeks since prior investigational therapy for melanoma
  • No prior small bowel resection that may significantly alter the absorption of everolimus
  • No prior sirolimus or its analogues
  • No prior radiotherapy to > 30% of bone marrow
  • No concurrent drugs that may induce CYP3A4 activity
  • No concurrent warfarin
  • No concurrent grapefruit or grapefruit juice
  • No concurrent use or planned use of vaccines containing live virus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521001

  Hide Study Locations
Locations
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80224-2522
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
North Colorado Medical Center
Greeley, Colorado, United States, 80631
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
McKee Medical Center
Loveland, Colorado, United States, 80539
Rose Medical Center
Denver, Colorado, United States, 80220
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
St. Joseph Hospital
Denver, Colorado, United States, 80218
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Swedish Medical Center
Englewood, Colorado, United States, 80110
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Graham Hospital
Canton, Illinois, United States, 61520
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Memorial Hospital
Carthage, Illinois, United States, 62321
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Proctor Hospital
Peoria, Illinois, United States, 61614
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60504
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
South Bend Clinic
South Bend, Indiana, United States, 46617
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Michigan
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hackley Hospital
Muskegon, Michigan, United States, 49442
Holland Community Hospital
Holland, Michigan, United States, 49423
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Metro Health Hospital
Wyoming, Michigan, United States, 49519
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, United States, 55102
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
United Hospital
Saint Paul, Minnesota, United States, 55102
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Fergus Falls, Minnesota, United States, 56537
Alexandria, Minnesota, United States, 56308
Fergus Falls, Minnesota, United States, 56537
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Community Medical Center
Missoula, Montana, United States, 59801
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls, Montana, United States, 59405
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
MeritCare Broadway
Fargo, North Dakota, United States, 58122
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Grandview Hospital
Dayton, Ohio, United States, 45405
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Mercy Medical Center
Springfield, Ohio, United States, 45504
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Ravi D. Rao, MD, MBBS Mayo Clinic
Investigator: Svetomir Markovic, MD, PhD Mayo Clinic
Investigator: William J. Maples, MD Mayo Clinic
Investigator: Michael K. Gornet, MD Mayo Clinic Hospital
Investigator: Edward T. Creagan, MD Mayo Clinic
Investigator: Barbara A. Pockaj, MD Mayo Clinic Hospital
Investigator: Judith S. Kaur, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: North Central Cancer Treatment Group ( Jan C. Buckner )
Study ID Numbers: CDR0000562166, NCCTG-N0675
Study First Received: August 24, 2007
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00521001     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma

Additional relevant MeSH terms:
Everolimus
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Immunosuppressive Agents
Temozolomide
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009