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Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma

2018년 9월 21일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

115

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Group I (sorafenib tosylate, temsirolimus)
Patients receive sorafenib tosylate and temsirolimus as in Phase I.
다른: 실험실 바이오마커 분석
상관 연구
의약품: 템시롤리무스
주어진 IV
다른 이름들:
  • 토리셀
  • CCI-779
  • CCI-779 라파마이신 아날로그
  • 세포 주기 억제제 779
  • 라파마이신 아날로그
  • 라파마이신 아날로그 CCI-779
의약품: 소라페닙 토실레이트
주어진 PO
다른 이름들:
  • 베이 54-9085
  • 넥사바
  • BAY 43-9006 토실레이트
  • 소라페닙
실험적: 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.
다른: 실험실 바이오마커 분석
상관 연구
절차: 기존 수술
수술을 받다
의약품: 템시롤리무스
주어진 IV
다른 이름들:
  • 토리셀
  • CCI-779
  • CCI-779 라파마이신 아날로그
  • 세포 주기 억제제 779
  • 라파마이신 아날로그
  • 라파마이신 아날로그 CCI-779
의약품: 소라페닙 토실레이트
주어진 PO
다른 이름들:
  • 베이 54-9085
  • 넥사바
  • BAY 43-9006 토실레이트
  • 소라페닙
실험적: 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.
다른: 실험실 바이오마커 분석
상관 연구
의약품: 템시롤리무스
주어진 IV
다른 이름들:
  • 토리셀
  • CCI-779
  • CCI-779 라파마이신 아날로그
  • 세포 주기 억제제 779
  • 라파마이신 아날로그
  • 라파마이신 아날로그 CCI-779
의약품: 소라페닙 토실레이트
주어진 PO
다른 이름들:
  • 베이 54-9085
  • 넥사바
  • BAY 43-9006 토실레이트
  • 소라페닙

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-free Survival
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Kurt Jaeckle, Alliance for Clinical Trials in Oncology

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2006년 3월 24일

기본 완료 (실제)

2013년 2월 1일

연구 완료 (실제)

2013년 2월 2일

연구 등록 날짜

최초 제출

2006년 5월 23일

QC 기준을 충족하는 최초 제출

2006년 5월 23일

처음 게시됨 (추정)

2006년 5월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 21일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2009-00652 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • U10CA180821 (미국 NIH 보조금/계약)
  • U10CA025224 (미국 NIH 보조금/계약)
  • CDR0000472240
  • NCCTG-N0572
  • N0572 (기타 식별자: CTEP)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

성인 교모세포종에 대한 임상 시험

실험실 바이오마커 분석에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Estonia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다