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Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

21 settembre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

115

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group I (sorafenib tosylate, temsirolimus)
Patients receive sorafenib tosylate and temsirolimus as in Phase I.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Droga: Temsirolimus
Dato IV
Altri nomi:
  • Torisel
  • CCI-779
  • Analogo della rapamicina CCI-779
  • Inibitore del ciclo cellulare 779
  • Analogo della rapamicina
Droga: Sorafenib tosilato
Dato PO
Altri nomi:
  • BAIA 54-9085
  • Nexavar
  • BAY 43-9006 Tosilato
  • sorafenib
Sperimentale: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Procedura: Chirurgia convenzionale
Sottoporsi ad intervento chirurgico
Droga: Temsirolimus
Dato IV
Altri nomi:
  • Torisel
  • CCI-779
  • Analogo della rapamicina CCI-779
  • Inibitore del ciclo cellulare 779
  • Analogo della rapamicina
Droga: Sorafenib tosilato
Dato PO
Altri nomi:
  • BAIA 54-9085
  • Nexavar
  • BAY 43-9006 Tosilato
  • sorafenib
Sperimentale: 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.
Altro: Analisi dei biomarcatori di laboratorio
Studi correlati
Droga: Temsirolimus
Dato IV
Altri nomi:
  • Torisel
  • CCI-779
  • Analogo della rapamicina CCI-779
  • Inibitore del ciclo cellulare 779
  • Analogo della rapamicina
Droga: Sorafenib tosilato
Dato PO
Altri nomi:
  • BAIA 54-9085
  • Nexavar
  • BAY 43-9006 Tosilato
  • sorafenib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Kurt Jaeckle, Alliance for Clinical Trials in Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 marzo 2006

Completamento primario (Effettivo)

1 febbraio 2013

Completamento dello studio (Effettivo)

2 febbraio 2013

Date di iscrizione allo studio

Primo inviato

23 maggio 2006

Primo inviato che soddisfa i criteri di controllo qualità

23 maggio 2006

Primo Inserito (Stima)

25 maggio 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2018

Ultimo verificato

1 settembre 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2009-00652 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (Sovvenzione/contratto NIH degli Stati Uniti)
  • U10CA025224 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000472240
  • NCCTG-N0572
  • N0572 (Altro identificatore: CTEP)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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