Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme
NCT ID: NCT00641706
Last Updated: 2014-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2008-07-31
2010-11-30
Brief Summary
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Detailed Description
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I. To determine the clinical efficacy of vorinostat (SAHA) and bortezomib, in terms of progression-free survival (PFS) at 6 months, in patients with progressive, recurrent glioblastoma multiforme.
SECONDARY OBJECTIVES:
I. To determine the clinical efficacy of this regimen, in terms of overall survival, PFS at 12 months, time to progression, and objective response rate, in these patients.
II. To identify molecular predictors of response in baseline tumor specimens from these patients.
III. To determine molecular changes in response to this regimen in tumor specimens from patients undergoing surgery.
OUTLINE: This is a multicenter study. Patients are stratified according to planned surgery (no \[stratum 1\] vs yes \[stratum 2\]).
STRATUM 1 (NOT UNDERGOING SURGERY): Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib intravenously (IV) on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
STRATUM 2 (UNDERGOING SURGERY): Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
Tumor tissue samples are collected at baseline and during surgery (stratum 2) for correlative laboratory studies. Tissue samples are analyzed for baseline total and phosphorylated AKT and p27\^KIp1 expression by IHC. Tissue samples from patients in stratum 2 are also analyzed for histone acetylation status; markers of proteasome inhibition; total and phosphorylated Bax expression by IHC; and gene expression profiles.
After completion of study therapy, patients are followed every 3 months for 2 years and then every 6 months thereafter.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stratum 1 (not undergoing surgery)
Patients receive oral vorinostat (SAHA) once daily on days 1-14 and bortezomib IV on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
vorinostat
Given orally
bortezomib
Given IV
Stratum 2 (undergoing surgery)
Patients receive oral SAHA once daily for 2 days prior to surgery and then on the day of surgery. Patients also receive bortezomib IV on the day of surgery. After receiving the 3rd dose of SAHA, patients undergo surgery to remove the tumor. Beginning at least 7 days after surgery, patients receive SAHA and bortezomib as in stratum 1.
vorinostat
Given orally
therapeutic conventional surgery
Patient undergoes surgery
bortezomib
Given IV
Interventions
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vorinostat
Given orally
therapeutic conventional surgery
Patient undergoes surgery
bortezomib
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gliosarcoma or other grade 4 astrocytoma variant (e.g., giant cell glioblastoma) allowed
* Recurrent disease
* Must have evidence of tumor progression by MRI or CT scan after radiotherapy or after the most recent antitumor therapy
* Bidimensionally measurable or evaluable disease by MRI or CT scan
* Patients receiving corticosteroids must be on a fixed dose for at least 1 week prior to baseline scan
* ECOG performance status 0-2
* WBC ≥ 3,000/mm³
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST ≤ 3 times ULN
* Creatinine normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after the last dose of vorinostat
* Willing to provide mandatory correlative laboratory tissue samples
* Able to take oral medications
* No uncontrolled infection
* No known hypersensitivity to any of the components of vorinostat or bortezomib
* No myocardial infarction or unstable angina within the past 6 months
* No congestive heart failure requiring use of ongoing maintenance therapy or history of life-threatening ventricular arrhythmias
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing or active infection
* Psychiatric illness or social situation that would limit compliance with study requirements
* No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with proper assessment of safety and toxicity of the prescribed study regimens
* Not immunocompromised
* Patients known to be HIV positive are eligible provided there is no clinical evidence of an immunocompromised state
* No peripheral neuropathy ≥ grade 2
* No peripheral neuropathy with pain ≥ grade 1
* No congenital long QT syndrome
* No prolonged OTC interval (\> 450 msec)
* No other concurrent anticancer therapy (other than hormonal therapy)
* At least 8 weeks since prior radiotherapy
* More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless there is a separate lesion on MRI that is not part of the prior treatment field
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No more than 1 prior chemotherapy regimen\* for progressive/recurrent disease (stratum 1)
* Patients in stratum 2 may have received any number of prior chemotherapy regimens\* for progressive/recurrent disease
* More than 2 weeks since prior small molecule cell cycle inhibitors
* More than 7 days since prior valproic acid
* More than 7 days since prior category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
* Quinidine, procainamide, disopyramide
* Amiodarone, sotalol, ibutilide, dofetilide
* Erythromycin, clarithromycin
* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide
* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,lidoflazine
* More than 4 weeks since prior bevacizumab
* No prior treatment with vorinostat or bortezomib
* No concurrent enzyme-inducing antiepileptic drugs (e.g., phenytoin,fosphenytoin, carbamazepine, phenobarbital, or primidone)
* No other concurrent potent CYP3A4 inducer (e.g., rifampin or St. John's wort)
* No other concurrent investigational therapy for the primary neoplasm
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Evanthia Galanis
Role: PRINCIPAL_INVESTIGATOR
North Central Cancer Treatment Group
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Exempla Saint Joseph Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
Saint Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital Association
Canton, Illinois, United States
Illinois CancerCare-Canton
Canton, Illinois, United States
Illinois CancerCare-Carthage
Carthage, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Eureka Hospital
Eureka, Illinois, United States
Illinois CancerCare-Eureka
Eureka, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, United States
Illinois CancerCare-Cottage
Galesburg, Illinois, United States
Illinois CancerCare-Havana
Havana, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States
Illinois CancerCare-Macomb
Macomb, Illinois, United States
Mcdonough District Hospital
Macomb, Illinois, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, United States
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, United States
Holy Family Medical Center
Monmouth, Illinois, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States
Bromenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center Foundation
Normal, Illinois, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States
Pekin Cancer Treatment Center
Pekin, Illinois, United States
Pekin Hospital
Pekin, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Illinois CancerCare-Peru
Peru, Illinois, United States
Illinois Valley Hospital
Peru, Illinois, United States
Illinois CancerCare-Princeton
Princeton, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States
Saint Margaret's Hospital
Spring Valley, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Carle Clinic-Urbana Main
Urbana, Illinois, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Hospital District Sixth of Harper County
Anthony, Kansas, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States
Billings Clinic
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, United States
Sanford Medical Center-Fargo
Fargo, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Mary Rutan Hospital
Bellefontaine, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton CCOP
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Saint Luke's Hospital
Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Genesis HealthCare System
Zanesville, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
AnMed Health Hospital
Anderson, South Carolina, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Midelfort Clinic-Clairemont Campus
Eau Claire, Wisconsin, United States
Mayo Clinic Health System Eau Claire Hospital - Luther Campus
Eau Claire, Wisconsin, United States
Agnesian Cancer Center
Fond du Lac, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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NCI-2009-00668
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000590113
Identifier Type: -
Identifier Source: secondary_id
NCCTG-N0779
Identifier Type: -
Identifier Source: secondary_id
N0779
Identifier Type: OTHER
Identifier Source: secondary_id
N0779
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00668
Identifier Type: -
Identifier Source: org_study_id
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