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Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

21. september 2018 opdateret af: National Cancer Institute (NCI)

A Phase I/II Trial of Sorafenib and CCI-779 in Patients With Recurrent Glioblastoma

This phase I/II trial studies the side effects and best dose of temsirolimus when given together with sorafenib tosylate and to see how well they work in treating patients with glioblastoma that has come back. Sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate and temsirolimus may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sorafenib tosylate with temsirolimus may kill more tumor cells.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary Objective -

Phase I (closed to accrual as of 01/11/2008):

To establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants (EIACs).

Phase II (closed to accrual as of 12/07/2012):

To assess the efficacy of temsirolimus and sorafenib in the treatment of recurrent glioblastoma in non-EIAC patients as measured by progression-free survival status at six months (PFS6).

Secondary Objectives -

Phase I (closed to accrual as of 01/11/2008):

I. To define the safety profile of temsirolimus and sorafenib in non-EIAC patients.

II. To assess the evidence of antitumor activity.

Phase II (closed to accrual as of 12/07/2012):

I. To assess the safety and toxicities of temsirolimus and sorafenib in the above-noted patient populations.

Outline: This is a multicenter, phase I, dose-escalation study followed by a phase II study.

Phase I (Arm A): Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Phase II: Patients are assigned to 1 of 3 treatment groups.

Group 1 (Arm B): Patients receive sorafenib and temsirolimus as in phase I at the MTD. (patients not undergoing surgery)

Group 2 (Arm C): Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. (patients undergoing surgery) After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD.

Group 3 (Arm D): Patient receive sorafenib and temsirolimus as in phase I at the MTD. (patients who have received prior anti-vascular endothelial growth factor [VEGF] therapy and are not undergoing surgery)

Biopsy or resected tissue and blood are collected prior to treatment (usually at diagnosis) and analyzed for biomarkers. After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

115

Fase

Fase 2
Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alaska
  - Anchorage, Alaska, Forenede Stater, 99508
    - Providence Alaska Medical Center
- Arizona
  - Scottsdale, Arizona, Forenede Stater, 85259
    - Mayo Clinic in Arizona
- Connecticut
  - Hartford, Connecticut, Forenede Stater, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
- Florida
  - Jacksonville, Florida, Forenede Stater, 32224-9980
    - Mayo Clinic in Florida
- Idaho
  - Boise, Idaho, Forenede Stater, 83706
    - Saint Alphonsus Cancer Care Center-Boise
- Illinois
  - Aurora, Illinois, Forenede Stater, 60504
    - Rush - Copley Medical Center
  - Bloomington, Illinois, Forenede Stater, 61704
    - Illinois CancerCare-Bloomington
  - Bloomington, Illinois, Forenede Stater, 61701
    - Saint Joseph Medical Center
  - Canton, Illinois, Forenede Stater, 61520
    - Illinois CancerCare-Canton
  - Canton, Illinois, Forenede Stater, 61520
    - Graham Hospital Association
  - Carthage, Illinois, Forenede Stater, 62321
    - Illinois CancerCare-Carthage
  - Carthage, Illinois, Forenede Stater, 62321
    - Memorial Hospital
  - Chicago, Illinois, Forenede Stater, 60612
    - Rush University Medical Center
  - Decatur, Illinois, Forenede Stater, 62526
    - Heartland Cancer Research NCORP
  - Effingham, Illinois, Forenede Stater, 62401
    - Saint Anthony Memorial Hospital
  - Eureka, Illinois, Forenede Stater, 61530
    - Illinois CancerCare-Eureka
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Illinois CancerCare-Galesburg
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Cottage Hospital
  - Havana, Illinois, Forenede Stater, 62644
    - Mason District Hospital
  - Havana, Illinois, Forenede Stater, 62644
    - Illinois CancerCare-Havana
  - Hopedale, Illinois, Forenede Stater, 61747
    - Hopedale Medical Complex - Hospital
  - Joliet, Illinois, Forenede Stater, 60435
    - Joliet Oncology-Hematology Associates Limited
  - Kewanee, Illinois, Forenede Stater, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Kewanee, Illinois, Forenede Stater, 61443
    - Kewanee Hospital
  - Macomb, Illinois, Forenede Stater, 61455
    - Illinois CancerCare-Macomb
  - Macomb, Illinois, Forenede Stater, 61455
    - Mcdonough District Hospital
  - Monmouth, Illinois, Forenede Stater, 61462
    - Illinois CancerCare-Monmouth
  - Monmouth, Illinois, Forenede Stater, 61462
    - Holy Family Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center Foundation
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Illinois CancerCare-Community Cancer Center
  - Ottawa, Illinois, Forenede Stater, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Ottawa, Illinois, Forenede Stater, 61350
    - Ottawa Regional Hospital and Healthcare Center
  - Pekin, Illinois, Forenede Stater, 61554
    - Illinois CancerCare-Pekin
  - Pekin, Illinois, Forenede Stater, 61554
    - OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  - Pekin, Illinois, Forenede Stater, 61554
    - Pekin Hospital
  - Peoria, Illinois, Forenede Stater, 61637
    - OSF Saint Francis Medical Center
  - Peoria, Illinois, Forenede Stater, 61615
    - Illinois CancerCare-Peoria
  - Peoria, Illinois, Forenede Stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forenede Stater, 61603
    - Methodist Medical Center of Illinois
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Illinois CancerCare-Princeton
  - Princeton, Illinois, Forenede Stater, 61356
    - Perry Memorial Hospital
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Saint Margaret's Hospital
  - Spring Valley, Illinois, Forenede Stater, 61362
    - Illinois CancerCare-Spring Valley
  - Urbana, Illinois, Forenede Stater, 61801
    - Carle Cancer Center
  - Urbana, Illinois, Forenede Stater, 61801
    - The Carle Foundation Hospital
- Indiana
  - Michigan City, Indiana, Forenede Stater, 46360
    - Franciscan Saint Anthony Health-Michigan City
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, Forenede Stater, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Des Moines, Iowa, Forenede Stater, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forenede Stater, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, Forenede Stater, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, Forenede Stater, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, Forenede Stater, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Des Moines, Iowa, Forenede Stater, 50307
    - Mercy Capitol
  - Mason City, Iowa, Forenede Stater, 50401
    - Mercy Medical Center - North Iowa
  - Sioux City, Iowa, Forenede Stater, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, Forenede Stater, 51104
    - Mercy Medical Center-Sioux City
- Kansas
  - Anthony, Kansas, Forenede Stater, 67003
    - Hospital District Sixth of Harper County
  - Chanute, Kansas, Forenede Stater, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, Forenede Stater, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, Forenede Stater, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, Forenede Stater, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, Forenede Stater, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, Forenede Stater, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, Forenede Stater, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, Forenede Stater, 67905
    - Cancer Center of Kansas-Liberal
  - Liberal, Kansas, Forenede Stater, 67901
    - Southwest Medical Center
  - McPherson, Kansas, Forenede Stater, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, Forenede Stater, 67114
    - Cancer Center of Kansas - Newton
  - Parsons, Kansas, Forenede Stater, 67357
    - Cancer Center of Kansas - Parsons
  - Pratt, Kansas, Forenede Stater, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, Forenede Stater, 67401
    - Cancer Center of Kansas - Salina
  - Wellington, Kansas, Forenede Stater, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, Forenede Stater, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, Forenede Stater, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, Forenede Stater, 67208
    - Associates In Womens Health
  - Wichita, Kansas, Forenede Stater, 67214
    - Wichita NCI Community Oncology Research Program
  - Wichita, Kansas, Forenede Stater, 67214
    - Via Christi Regional Medical Center
  - Winfield, Kansas, Forenede Stater, 67156
    - Cancer Center of Kansas - Winfield
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - Michigan Cancer Research Consortium NCORP
  - Battle Creek, Michigan, Forenede Stater, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, Forenede Stater, 49307
    - Spectrum Health Big Rapids Hospital
  - Dearborn, Michigan, Forenede Stater, 48124
    - Beaumont Hospital-Dearborn
  - Detroit, Michigan, Forenede Stater, 48236
    - Saint John Hospital and Medical Center
  - Escanaba, Michigan, Forenede Stater, 49829
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, Forenede Stater, 48532
    - Genesys Regional Medical Center-West Flint Campus
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Cancer Research Consortium of West Michigan NCORP
  - Iron Mountain, Michigan, Forenede Stater, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, Forenede Stater, 49201
    - Allegiance Health
  - Lansing, Michigan, Forenede Stater, 48912
    - Sparrow Hospital
  - Livonia, Michigan, Forenede Stater, 48154
    - Saint Mary Mercy Hospital
  - Muskegon, Michigan, Forenede Stater, 49444
    - Mercy Health Mercy Campus
  - Pontiac, Michigan, Forenede Stater, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, Forenede Stater, 48060
    - Lake Huron Medical Center
  - Saginaw, Michigan, Forenede Stater, 48601
    - Saint Mary's of Michigan
  - Traverse City, Michigan, Forenede Stater, 49684
    - Munson Medical Center
  - Warren, Michigan, Forenede Stater, 48093
    - Saint John Macomb-Oakland Hospital
  - Wyoming, Michigan, Forenede Stater, 49519
    - Metro Health Hospital
- Minnesota
  - Alexandria, Minnesota, Forenede Stater, 56308
    - Medini, Eitan MD (UIA Investigator)
  - Bemidji, Minnesota, Forenede Stater, 56601
    - Sanford Clinic North-Bemidgi
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, Forenede Stater, 55433
    - Mercy Hospital
  - Duluth, Minnesota, Forenede Stater, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, Forenede Stater, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, Forenede Stater, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview-Southdale Hospital
  - Fergus Falls, Minnesota, Forenede Stater, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fergus Falls, Minnesota, Forenede Stater, 56537
    - Etzell, Paul S MD (UIA Investigator)
  - Fergus Falls, Minnesota, Forenede Stater, 56537
    - Swenson, Wade II, MD (UIA Investigator)
  - Fridley, Minnesota, Forenede Stater, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, Forenede Stater, 55350
    - Hutchinson Area Health Care
  - Litchfield, Minnesota, Forenede Stater, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Minnesota Cooperative Group Outreach Program
  - New Ulm, Minnesota, Forenede Stater, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, Forenede Stater, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic
  - Saint Cloud, Minnesota, Forenede Stater, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Cloud, Minnesota, Forenede Stater, 56303
    - Saint Cloud Hospital
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - Saint Joseph's Hospital - Healtheast
  - Shakopee, Minnesota, Forenede Stater, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, Forenede Stater, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forenede Stater, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Woodwinds Health Campus
- Nebraska
  - Lincoln, Nebraska, Forenede Stater, 68510
    - Nebraska Cancer Research Center
  - Omaha, Nebraska, Forenede Stater, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, Forenede Stater, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, Forenede Stater, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, Forenede Stater, 68131
    - Creighton University Medical Center
  - Omaha, Nebraska, Forenede Stater, 68106
    - Missouri Valley Cancer Consortium
- North Carolina
  - Rutherfordton, North Carolina, Forenede Stater, 28139
    - Rutherford Hospital
  - Winston-Salem, North Carolina, Forenede Stater, 27104
    - Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Sanford Bismarck Medical Center
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Mid Dakota Clinic
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Saint Alexius Medical Center
  - Fargo, North Dakota, Forenede Stater, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, Forenede Stater, 58122
    - Sanford Clinic North-Fargo
  - Fargo, North Dakota, Forenede Stater, 58122
    - Roger Maris Cancer Center
  - Grand Forks, North Dakota, Forenede Stater, 58201
    - Altru Cancer Center
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, Forenede Stater, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Danville, Pennsylvania, Forenede Stater, 17822
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, Forenede Stater, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - State College, Pennsylvania, Forenede Stater, 16801
    - Geisinger Medical Group
  - Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - AnMed Health Cancer Center
  - Anderson, South Carolina, Forenede Stater, 29621
    - AnMed Health Hospital
  - Greenville, South Carolina, Forenede Stater, 29601
    - Saint Francis Hospital
  - Spartanburg, South Carolina, Forenede Stater, 29303
    - Spartanburg Medical Center
- South Dakota
  - Rapid City, South Dakota, Forenede Stater, 57701
    - Rapid City Regional Hospital
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, Forenede Stater, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, Forenede Stater, 57104
    - Sanford Cancer Center Oncology Clinic
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Medical X-Ray Center
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera McKennan Hospital and University Health Center
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22908
    - University of Virginia Cancer Center
  - Richmond, Virginia, Forenede Stater, 23298
    - Virginia Commonwealth University/Massey Cancer Center
- Washington
  - Seattle, Washington, Forenede Stater, 98101
    - Virginia Mason Medical Center
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, Forenede Stater, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, Forenede Stater, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Manitowoc, Wisconsin, Forenede Stater, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, Forenede Stater, 54143
    - Bay Area Medical Center
  - Oconto Falls, Wisconsin, Forenede Stater, 54154
    - Green Bay Oncology - Oconto Falls
  - Sheboygan, Wisconsin, Forenede Stater, 53081
    - HSHS Saint Nicholas Hospital
  - Sturgeon Bay, Wisconsin, Forenede Stater, 54235
    - Green Bay Oncology - Sturgeon Bay

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after surgery as possible
=< 2 prior systemic chemotherapy regimens
Histological confirmation of a grade 4 astrocytoma (glioblastoma) or gliosarcoma, at primary diagnosis or recurrence by World Health Organization (WHO) criteria; central pathology review is mandatory prior to study entry to confirm eligibility
Evidence of tumor progression by magnetic resonance imaging (MRI) or computed tomography (CT) scan following radiation therapy (RT) or following the most recent anti-tumor therapy
Bidimensionally measurable or evaluable disease by MRI or CT scan
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
>= 12 weeks since the completion of RT
Fixed or decreasing dose of corticosteroids (or no corticosteroids) >= 1 week prior to registration
>= 1 week from minor surgery other than venous line placement and > 3 weeks from major surgery (except for patients undergoing tumor tissue acquisition)
>= 4 weeks since prior cytotoxic chemotherapy (>= 6 weeks for nitrosoureas)
>= 2 weeks from cytostatic chemotherapy such as tamoxifen, cis-retinoic acid, or thalidomide (address questions regarding such agents to study chair)
White blood cells (WBC) >= 3,000/mm^3
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin (Hgb) >= 10 gm/dL
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.5 x ULN
Creatinine =< 2.0 x ULN
Serum cholesterol =< 350 mg/dL
Serum triglycerides =< 400 mg/dL
Willingness to provide the biologic specimens as required by the protocol; (please note that the willingness to participate pertains only to the patient and does not factor in the institution?s ability to participate in any part of the translational component)

Exclusion Criteria:

Prior intratumoral chemotherapy (e.g., Gliadel or IL13-PE38QQR), stereotactic radiosurgery, or interstitial brachytherapy unless there is a separate lesion on MRI which is not part of the previous treatment field or there is proof of recurrent disease based on biopsy, MRI spectroscopy, or positron emission tomography (PET) scan
Prior CCI-779, sorafenib, or other agents specifically targeting mammalian target of rapamycin (mTOR) or raf; patients receiving prior agents inhibiting VEGF or VEGF receptor (R) (prior anti-VEGF group) are eligible but: 1) must be at least four weeks from last treatment with the agent(s); and 2) must have recovered from any clinically relevant toxicities attributable to this agent(s)
Evidence of bleeding diathesis or coagulopathy
- Note: Patients on prophylactic anticoagulation therapy (e.g., low-dose warfarin) are eligible provided their coagulation parameter levels are as follows: prothrombin time (International Normalized Ratio [INR] of prothrombin time) < 1.1 x institutional upper limit of normal
- Note: Patients on full-dose anticoagulants (e.g., warfarin) are eligible provided that both of the following criteria are met: a) the patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin, and b) the patient has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
International normalized ration (INR) > 1.5 (unless the patient is on full-dose warfarin)
Receiving enzyme-inducing antiepileptic drugs (EIAEDs; e.g., phenytoin, fosphenytoin, carbamazepine, phenobarbital, or primidone) or any other potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer, such as rifampin or St. John?s wort
Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow pills
Hypertension with systolic blood pressure of > 140 mmHg or diastolic pressure > 90 mmHg; however, patients with well-controlled hypertension are eligible
Uncontrolled infection
Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Known hypersensitivity to any of the components of CCI-779 or sorafenib
Other active malignancy
Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situation that would preclude study compliance with study requirements
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive; HIV-positive patients on combination antiretroviral therapy are ineligible
Receiving any investigational agents other than CCI-779 and sorafenib
Significant intratumoral, intracerebral, or subarachnoid hemorrhage on baseline MRI or CT, or other history of significant intratumoral, intracerebral, or subarachnoid hemorrhage

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Group I (sorafenib tosylate, temsirolimus) Patients receive sorafenib tosylate and temsirolimus as in Phase I.	Andet: Laboratoriebiomarkøranalyse Korrelative undersøgelser Medicin: Temsirolimus Givet IV Andre navne: Torisel CCI-779 CCI-779 Rapamycin Analog Cellecyklushæmmer 779 Rapamycin Analog Rapamycin Analog CCI-779 Medicin: Sorafenib tosylat Givet PO Andre navne: BAY 54-9085 Nexavar BAY 43-9006 Tosylate sorafenib
Eksperimentel: Group II (sorafenib tosylate, temsirolimus, surgery) Patients receive sorafenib tosylate PO BID on days 1-8 and temsirolimus IV over 30 minutes on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib tosylate and temsirolimus as in Phase I.	Andet: Laboratoriebiomarkøranalyse Korrelative undersøgelser Procedure: Konventionel kirurgi Gennemgå operation Medicin: Temsirolimus Givet IV Andre navne: Torisel CCI-779 CCI-779 Rapamycin Analog Cellecyklushæmmer 779 Rapamycin Analog Rapamycin Analog CCI-779 Medicin: Sorafenib tosylat Givet PO Andre navne: BAY 54-9085 Nexavar BAY 43-9006 Tosylate sorafenib
Eksperimentel: Group III (sorafenib tosylate, temsirolimus, anti-VEGF) Patients who have received prior anti-VEGF therapy and are not undergoing surgery receive sorafenib tosylate and temsirolimus as in Phase I.	Andet: Laboratoriebiomarkøranalyse Korrelative undersøgelser Medicin: Temsirolimus Givet IV Andre navne: Torisel CCI-779 CCI-779 Rapamycin Analog Cellecyklushæmmer 779 Rapamycin Analog Rapamycin Analog CCI-779 Medicin: Sorafenib tosylat Givet PO Andre navne: BAY 54-9085 Nexavar BAY 43-9006 Tosylate sorafenib

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Progression-free Survival Tidsramme: At 6 months	The primary endpoint is the proportion of patients alive and progression-free 6 months after study treatment initiation. If more than 41 evaluable patients are accrued in group 1 or group 3, the additional patients will not be used to evaluate the decision rule for that group or otherwise used in any decision-making processes. However, they will be included in the final point and confidence interval estimates for that group. The 'success' probability, i.e., 6-month progression-free survival percentage, for each of group 1 and group 3 will be estimated as the number of evaluable patients still alive at 6 months divided by the total number of evaluable patients followed for at least 6 months. Ninety-five percent confidence intervals for the 'success' probability will be calculated according to the approach of Duffy and Santner. Progression is defined as a 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.	At 6 months

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Overall Survival Tidsramme: From start of study registration to death due to any cause or until last follow-up, up to 5 years	The overall survival distribution will be estimated using the method of Kaplan-Meier.	From start of study registration to death due to any cause or until last follow-up, up to 5 years
Objective Response, as Determined by a Neurological Exam, MRI, and/or CT Measurement Tidsramme: Up to 5 years	The proportion of patients in each response category will be summarized and 90% confidence intervals calculated assuming that the incidence of response is binomially distributed.	Up to 5 years
Progression-free Survival Tidsramme: Time from study registration to date of disease progression or last follow-up, assessed up to 5 years	Kaplan-Meier survival curves will be used to estimate progression-time distributions.	Time from study registration to date of disease progression or last follow-up, assessed up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

Ledende efterforsker: Kurt Jaeckle, Alliance for Clinical Trials in Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. marts 2006

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

2. februar 2013

Datoer for studieregistrering

Først indsendt

23. maj 2006

Først indsendt, der opfyldte QC-kriterier

23. maj 2006

Først opslået (Skøn)

25. maj 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCI-2009-00652 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180821 (U.S. NIH-bevilling/kontrakt)
U10CA025224 (U.S. NIH-bevilling/kontrakt)
CDR0000472240
NCCTG-N0572
N0572 (Anden identifikator: CTEP)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Neuro-farmakologisk undersøgelse af ketoconazol til højgradige gliomer

Glioblastom | Glioblastoma Multiforme | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernen

Forenede Stater
Milton S. Hershey Medical Center
National Cancer Institute (NCI)

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Neuro-farmakologiske egenskaber ved genbrugt posaconazol i glioblastom: et klinisk fase 0-forsøg

Glioblastom | Glioblastoma Multiforme | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernen

Forenede Stater
Jasper Gerritsen
Massachusetts General Hospital; Universitaire Ziekenhuizen KU Leuven; University... og andre samarbejdspartnere

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RESBIOP-studiet: Resektion versus biopsi hos højgradige gliompatienter (ENCRAM 2202) (RESBIOP)

Glioblastom | Glioblastoma Multiforme | Glioblastom, IDH-vildtype | Glioblastoma Multiforme, voksen | Glioblastoma Multiforme i hjernen

Forenede Stater, Belgien, Schweiz, Tyskland, Holland
University of Utah

Trukket tilbage

Foreløbig vurdering af [18F] Fluciclatid (GE [18F]AH111585) i Glioblastoma Multiforme behandlet med Bevacizumab

Glioblastoma Multiforme (GBM)

Forenede Stater
TVAX Biomedical
FDA Office of Orphan Products Development

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Undersøgelse af neoantigen-specifik adoptiv T-celleterapi til nydiagnosticeret o6-methylguanin-DNA-methyltransferase (MGMT) Negativ Glioblastoma Multiforme (GBM)

Glioblastoma Multiforme i hjernen

Forenede Stater
Shenzhen Geno-Immune Medical Institute

Tilmelding efter invitation

Immunogen-modificerede T (IgT) celler mod Glioblastoma Multiforme

Glioblastoma Multiforme | Glioblastoma Multiforme i hjernen

Kina
University of Roma La Sapienza

Afsluttet

Effekt af dyb TMS på permeabiliteten af BBB hos patienter med Glioblastoma Multiforme: en pilotundersøgelse

Glioblastoma Multiforme i hjernen
Imperial College London

Rekruttering

[18F]FPIA PET-CT i Glioblastoma Multiforme (GBM) (FAM-GBM)

Glioblastoma Multiforme i hjernen

Det Forenede Kongerige
Clinique Neuro-Outaouais

Afsluttet

Avelumab hos patienter med nyligt diagnosticeret Glioblastoma Multiforme (SEJ)

Glioblastoma Multiforme i hjernen

Canada
Sunnybrook Health Sciences Centre

Rekruttering

UNIty-baseret MR-Linac guidet adaptiv radioterapi til højgradig gliom-3 (UNITED-3) (UNITED-3)

Glioblastoma Multiforme, voksen

Canada

Kliniske forsøg med Laboratoriebiomarkøranalyse

Liao Jian An

Rekruttering

Meridianenergiændringer hos patienter med hoved- og nakkekræft efter kemoterapi eller strålebehandling

Hoved- og halskræft

Taiwan
Fondation Lenval

Trukket tilbage

Indflydelse af træthed på gangmønsteret hos patienter med cerebral parese.

Cerebral Parese

Frankrig
Progenity, Inc.

Afsluttet

Udvidet ikke-invasiv genomisk medicinsk vurdering: Enigma-undersøgelsen

Downs syndrom | Aneuploidi | DiGeorges syndrom | Turners syndrom | Klinefelters syndrom | Kromosom sletning | Edwards syndrom | Patau syndrom

Forenede Stater
IRCCS Eugenio Medea

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Biomarkørers baner for tidlig intervention hos søskende til børn med autismespektrumforstyrrelse

Autismespektrumforstyrrelse | Tidlig indsats

Italien
Oregon Health and Science University
4DMedical

Tilmelding efter invitation

Ventilationsubalancer ved let til moderat kronisk obstruktiv lungesygdom (VAPOR)

Lungesygdomme | KOL | Luftvejssygdom | Dyspnø

Forenede Stater
IRCCS Eugenio Medea

Rekruttering

Bekræft præstationen i klinisk praksis af den fordybende Virtual Reality Platform GRAIL (Gait Real-time Analysis Interactive Lab)

Cerebral Parese | Erhvervet hjerneskade

Italien
Modarres Hospital

Afsluttet

Renal parenkymal kernenålbiopsi

Komplikationer | Billedstyret biopsi | Nyre Glomerulus

Iran, Islamisk Republik
Healthy.io Ltd.

Afsluttet

[Prøvning af enhed, der ikke er godkendt eller godkendt af U.S. FDA]

Albuminuri

Forenede Stater
Medwave Estudios Limitada
Asociación Chilena de Seguridad

Ukendt

Diagnostisk værdi af arbejdsbelastningsanalyseinstrument til at påvise erhvervsmæssige risici ved muskel- og skelettilstande i øvre lemmer (ACT-ACHS)

Erhvervsmæssig eksponering | Muskuloskeletal sygdom

Chile
Alcon Research

Afsluttet

Clareon IOL retrospektiv dataindsamling

Astigmatisme | Aphakia

Forenede Stater

Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

A Phase I/II Trial of Sorafenib and CCI-779 in Patients With Recurrent Glioblastoma

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Voksen glioblastom

Kliniske forsøg med Laboratoriebiomarkøranalyse

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer