- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641706
Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme
Phase II Study of Vorinostat (SAHA) in Combination With Bortezomib (PS-341) in Patients With Recurrent Glioblastoma Multiforme
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Colorado
-
Aurora, Colorado, United States, 80012
- The Medical Center of Aurora
-
Boulder, Colorado, United States, 80301
- Boulder Community Hospital
-
Colorado Springs, Colorado, United States, 80907
- Penrose-Saint Francis Healthcare
-
Denver, Colorado, United States, 80210
- Porter Adventist Hospital
-
Denver, Colorado, United States, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver, Colorado, United States, 80220
- Rose Medical Center
-
Denver, Colorado, United States, 80218
- Exempla Saint Joseph Hospital
-
Denver, Colorado, United States, 80224-2522
- Colorado Cancer Research Program CCOP
-
Englewood, Colorado, United States, 80113
- Swedish Medical Center
-
Grand Junction, Colorado, United States, 81502
- Saint Mary's Hospital and Regional Medical Center
-
Greeley, Colorado, United States, 80631
- North Colorado Medical Center
-
Lakewood, Colorado, United States, 80228
- Saint Anthony Hospital
-
Lone Tree, Colorado, United States, 80124
- Sky Ridge Medical Center
-
Longmont, Colorado, United States, 80501
- Longmont United Hospital
-
Loveland, Colorado, United States, 80539
- McKee Medical Center
-
Pueblo, Colorado, United States, 81004
- Saint Mary Corwin Medical Center
-
Thornton, Colorado, United States, 80229
- North Suburban Medical Center
-
Wheat Ridge, Colorado, United States, 80033
- Exempla Lutheran Medical Center
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- Rush - Copley Medical Center
-
Bloomington, Illinois, United States, 61701
- Saint Joseph Medical Center
-
Bloomington, Illinois, United States, 61701
- Illinois CancerCare-Bloomington
-
Canton, Illinois, United States, 61520
- Illinois CancerCare-Canton
-
Canton, Illinois, United States, 61520
- Graham Hospital Association
-
Carthage, Illinois, United States, 62321
- Illinois CancerCare-Carthage
-
Carthage, Illinois, United States, 62321
- Memorial Hospital
-
Eureka, Illinois, United States, 61530
- Illinois CancerCare-Eureka
-
Eureka, Illinois, United States, 61530
- Eureka Hospital
-
Galesburg, Illinois, United States, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, United States, 61401
- Illinois CancerCare Galesburg
-
Galesburg, Illinois, United States, 61401
- Illinois CancerCare-Cottage
-
Havana, Illinois, United States, 62644
- Mason District Hospital
-
Havana, Illinois, United States, 62644
- Illinois CancerCare-Havana
-
Hopedale, Illinois, United States, 61747
- Hopedale Medical Complex - Hospital
-
Joliet, Illinois, United States, 60435
- Joliet Oncology-Hematology Associates Limited
-
Kewanee, Illinois, United States, 61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb, Illinois, United States, 61455
- Illinois CancerCare-Macomb
-
Macomb, Illinois, United States, 61455
- Mcdonough District Hospital
-
Moline, Illinois, United States, 61265
- Garneau, Stewart C MD (UIA Investigator)
-
Moline, Illinois, United States, 61265
- Porubcin, Michael MD (UIA Investigator)
-
Moline, Illinois, United States, 61265
- Sharis, Christine M MD (UIA Investigator)
-
Moline, Illinois, United States, 61265
- Stoffel, Thomas J MD (UIA Investigator)
-
Monmouth, Illinois, United States, 61462
- Illinois CancerCare-Monmouth
-
Monmouth, Illinois, United States, 61462
- Holy Family Medical Center
-
Normal, Illinois, United States, 61761
- Community Cancer Center Foundation
-
Normal, Illinois, United States, 61761
- Bromenn Regional Medical Center
-
Normal, Illinois, United States, 61761
- Illinois CancerCare-Community Cancer Center
-
Ottawa, Illinois, United States, 61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa, Illinois, United States, 61350
- Ottawa Regional Hospital and Healthcare Center
-
Pekin, Illinois, United States, 61554
- Pekin Cancer Treatment Center
-
Pekin, Illinois, United States, 61554
- Pekin Hospital
-
Pekin, Illinois, United States, 61603
- Illinois CancerCare-Pekin
-
Peoria, Illinois, United States, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, United States, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, United States, 61614
- Proctor Hospital
-
Peoria, Illinois, United States, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, United States, 61615
- Illinois Oncology Research Association CCOP
-
Peru, Illinois, United States, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, United States, 61354
- Illinois Valley Hospital
-
Princeton, Illinois, United States, 61356
- Illinois CancerCare-Princeton
-
Princeton, Illinois, United States, 61356
- Perry Memorial Hospital
-
Spring Valley, Illinois, United States, 61362
- Saint Margaret's Hospital
-
Spring Valley, Illinois, United States, 61362
- Illinois CancerCare-Spring Valley
-
Urbana, Illinois, United States, 61801
- Carle Cancer Center
-
Urbana, Illinois, United States, 61801
- Carle Clinic-Urbana Main
-
-
Indiana
-
Beech Grove, Indiana, United States, 46107
- Saint Francis Hospital and Health Centers
-
Elkhart, Indiana, United States, 46515
- Elkhart General Hospital
-
Kokomo, Indiana, United States, 46904
- Community Howard Regional Health
-
La Porte, Indiana, United States, 46350
- IU Health La Porte Hospital
-
Michigan City, Indiana, United States, 46360
- Franciscan Saint Anthony Health-Michigan City
-
Mishawaka, Indiana, United States, 46545-1470
- Saint Joseph Regional Medical Center-Mishawaka
-
Richmond, Indiana, United States, 47374
- Reid Hospital and Health Care Services
-
South Bend, Indiana, United States, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, United States, 46628
- Northern Indiana Cancer Research Consortium
-
South Bend, Indiana, United States, 46617
- South Bend Clinic
-
-
Iowa
-
Bettendorf, Iowa, United States, 52722
- Constantinou, Costas L MD (UIA Investigator)
-
Cedar Rapids, Iowa, United States, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, United States, 52403
- Oncology Associates at Mercy Medical Center
-
Cedar Rapids, Iowa, United States, 52403
- Cedar Rapids Oncology Association
-
Clive, Iowa, United States, 50325
- Medical Oncology and Hematology Associates-West Des Moines
-
Des Moines, Iowa, United States, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, United States, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, United States, 50309
- Medical Oncology and Hematology Associates-Des Moines
-
Des Moines, Iowa, United States, 50316
- Iowa Lutheran Hospital
-
Des Moines, Iowa, United States, 50314
- Medical Oncology and Hematology Associates-Laurel
-
Des Moines, Iowa, United States, 50307
- Mercy Capitol
-
Des Moines, Iowa, United States, 50309
- Iowa Oncology Research Association CCOP
-
Sioux City, Iowa, United States, 51104
- Saint Luke's Regional Medical Center
-
Sioux City, Iowa, United States, 51101
- Siouxland Hematology Oncology Associates
-
Sioux City, Iowa, United States, 51104
- Mercy Medical Center-Sioux City
-
-
Kansas
-
Anthony, Kansas, United States, 67003
- Hospital District Sixth of Harper County
-
-
Michigan
-
Adrian, Michigan, United States, 49221
- Bixby Medical Center
-
Adrian, Michigan, United States, 49221
- Hickman Cancer Center
-
Battle Creek, Michigan, United States, 49017
- Bronson Battle Creek
-
Big Rapids, Michigan, United States, 49307
- Spectrum Health Big Rapids Hospital
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health at Butterworth Campus
-
Grand Rapids, Michigan, United States, 49503
- Mercy Health Saint Mary's
-
Grand Rapids, Michigan, United States, 49503
- Grand Rapids Clinical Oncology Program
-
Monroe, Michigan, United States, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, United States, 48162
- Community Cancer Center of Monroe
-
Muskegon, Michigan, United States, 49444
- Mercy Health Mercy Campus
-
Muskegon, Michigan, United States, 49442
- Mercy Health Partners-Hackley Campus
-
St. Joseph, Michigan, United States, 49085
- Lakeland Hospital
-
Traverse City, Michigan, United States, 49684
- Munson Medical Center
-
Wyoming, Michigan, United States, 49519
- Metro Health Hospital
-
-
Minnesota
-
Bemidji, Minnesota, United States, 56601
- Sanford Clinic North-Bemidgi
-
Burnsville, Minnesota, United States, 55337
- Fairview Ridges Hospital
-
Coon Rapids, Minnesota, United States, 55433
- Mercy Hospital
-
Duluth, Minnesota, United States, 55805
- Essentia Health Saint Mary's Medical Center
-
Duluth, Minnesota, United States, 55805
- Miller-Dwan Hospital
-
Duluth, Minnesota, United States, 55805
- Essentia Health Duluth Clinic CCOP
-
Edina, Minnesota, United States, 55435
- Fairview-Southdale Hospital
-
Fergus Falls, Minnesota, United States, 56537
- Lake Region Healthcare Corporation-Cancer Care
-
Fridley, Minnesota, United States, 55432
- Unity Hospital
-
Hutchinson, Minnesota, United States, 55350
- Hutchinson Area Health Care
-
Litchfield, Minnesota, United States, 55355
- Meeker County Memorial Hospital
-
Maplewood, Minnesota, United States, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, United States, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, United States, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, United States, 55407
- Virginia Piper Cancer Institute
-
Robbinsdale, Minnesota, United States, 55422
- North Memorial Medical Health Center
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
Saint Louis Park, Minnesota, United States, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Louis Park, Minnesota, United States, 55416
- Metro-Minnesota CCOP
-
Saint Paul, Minnesota, United States, 55101
- Regions Hospital
-
Saint Paul, Minnesota, United States, 55102
- United Hospital
-
Shakopee, Minnesota, United States, 55379
- Saint Francis Regional Medical Center
-
Waconia, Minnesota, United States, 55387
- Ridgeview Medical Center
-
Woodbury, Minnesota, United States, 55125
- Minnesota Oncology and Hematology PA-Woodbury
-
-
Montana
-
Billings, Montana, United States, 59101
- Saint Vincent Healthcare
-
Billings, Montana, United States, 59101
- Northern Rockies Radiation Oncology Center
-
Billings, Montana, United States, 59101
- Montana Cancer Consortium CCOP
-
Billings, Montana, United States, 59102
- Hematology-Oncology Centers of the Northern Rockies PC
-
Billings, Montana, United States, 59107-7000
- Billings Clinic
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Hospital
-
Bozeman, Montana, United States, 59715
- Bozeman Deaconess Cancer Center
-
Butte, Montana, United States, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, United States, 59405
- Great Falls Clinic
-
Great Falls, Montana, United States, 59405
- Berdeaux, Donald MD (UIA Investigator)
-
Havre, Montana, United States, 59501
- Northern Montana Hospital
-
Helena, Montana, United States, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, United States, 59901
- Kalispell Regional Medical Center
-
Kalispell, Montana, United States, 59901
- Glacier Oncology PLLC
-
Kalispell, Montana, United States, 59901
- Kalispell Medical Oncology
-
Missoula, Montana, United States, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, United States, 59804
- Guardian Oncology and Center for Wellness
-
Missoula, Montana, United States, 59801
- Community Medical Hospital
-
Missoula, Montana, United States, 59802
- Montana Cancer Specialists
-
-
North Carolina
-
Rutherfordton, North Carolina, United States, 28139
- Rutherford Hospital
-
-
North Dakota
-
Bismarck, North Dakota, United States, 58501
- Sanford Bismarck Medical Center
-
Bismarck, North Dakota, United States, 58501
- Bismarck Cancer Center
-
Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic
-
Bismarck, North Dakota, United States, 58501
- Saint Alexius Medical Center
-
Fargo, North Dakota, United States, 58122
- Sanford Clinic North-Fargo
-
Fargo, North Dakota, United States, 58122
- Sanford Medical Center-Fargo
-
Grand Forks, North Dakota, United States, 58201
- Altru Cancer Center
-
-
Ohio
-
Bellefontaine, Ohio, United States, 43311
- Mary Rutan Hospital
-
Bowling Green, Ohio, United States, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Clyde, Ohio, United States, 43410
- North Coast Cancer Care-Clyde
-
Columbus, Ohio, United States, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, United States, 43228
- Doctors Hospital
-
Columbus, Ohio, United States, 43215
- Grant Medical Center
-
Columbus, Ohio, United States, 43222
- Mount Carmel Health Center West
-
Dayton, Ohio, United States, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, United States, 45409
- Miami Valley Hospital
-
Dayton, Ohio, United States, 45415
- Samaritan North Health Center
-
Dayton, Ohio, United States, 45405
- Grandview Hospital
-
Dayton, Ohio, United States, 45420
- Dayton CCOP
-
Delaware, Ohio, United States, 43015
- Grady Memorial Hospital
-
Elyria, Ohio, United States, 44035
- Hematology Oncology Center Incorporated
-
Findlay, Ohio, United States, 45840
- Blanchard Valley Hospital
-
Franklin, Ohio, United States, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Greenville, Ohio, United States, 45331
- Wayne Hospital
-
Kettering, Ohio, United States, 45429
- Kettering Medical Center
-
Lancaster, Ohio, United States, 43130
- Fairfield Medical Center
-
Lima, Ohio, United States, 45804
- Lima Memorial Hospital
-
Marietta, Ohio, United States, 45750
- Marietta Memorial Hospital
-
Maumee, Ohio, United States, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Maumee, Ohio, United States, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Maumee, Ohio, United States, 43537
- Saint Luke's Hospital
-
Newark, Ohio, United States, 43055
- Licking Memorial Hospital
-
Oregon, Ohio, United States, 43616
- Saint Charles Hospital
-
Oregon, Ohio, United States, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Sandusky, Ohio, United States, 44870
- North Coast Cancer Care
-
Sylvania, Ohio, United States, 43560
- Flower Hospital
-
Tiffin, Ohio, United States, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, United States, 43608
- Saint Vincent Mercy Medical Center
-
Toledo, Ohio, United States, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, United States, 43614
- University of Toledo
-
Toledo, Ohio, United States, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, United States, 43606
- The Toledo Hospital/Toledo Children's Hospital
-
Toledo, Ohio, United States, 43623
- Mercy Saint Anne Hospital
-
Troy, Ohio, United States, 45373
- Upper Valley Medical Center
-
Wauseon, Ohio, United States, 43567
- Fulton County Health Center
-
Westerville, Ohio, United States, 43081
- Saint Ann's Hospital
-
Wilmington, Ohio, United States, 45177
- Clinton Memorial Hospital
-
Xenia, Ohio, United States, 45385
- Greene Memorial Hospital
-
Zanesville, Ohio, United States, 43701
- Genesis Healthcare System
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822-2001
- Geisinger Medical Center
-
Hazleton, Pennsylvania, United States, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
State College, Pennsylvania, United States, 16801
- Geisinger Medical Group
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Geisinger Wyoming Valley
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- AnMed Health Hospital
-
Spartanburg, South Carolina, United States, 29303
- Spartanburg Regional Medical Center
-
Spartanburg, South Carolina, United States, 29303
- Upstate Carolina CCOP
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57701
- Rapid City Regional Hospital
-
-
Virginia
-
Fredericksburg, Virginia, United States, 22401
- Fredericksburg Oncology Inc
-
-
Wisconsin
-
Eau Claire, Wisconsin, United States, 54702
- Midelfort Clinic-Clairemont Campus
-
Eau Claire, Wisconsin, United States, 54703
- Mayo Clinic Health System Eau Claire Hospital - Luther Campus
-
Fond Du Lac, Wisconsin, United States, 54935
- Agnesian Cancer Center
-
-
Wyoming
-
Casper, Wyoming, United States, 82609
- Rocky Mountain Oncology
-
Sheridan, Wyoming, United States, 82801
- Welch Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed glioblastoma multiforme
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Given orally
Other Names:
Given IV
Other Names:
|
Experimental: 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.
|
Given orally
Other Names:
Given IV
Other Names:
Patient undergoes surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival at 6 Months
Time Frame: At 6 months
|
Estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients).
A patient is classified as a success if alive and progression-free at 6 months.
For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
|
At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From study registration to date of death due to any cause or last follow-up (up to 5 years)
|
Estimated using Kaplan-Meier survival curve.
|
From study registration to date of death due to any cause or last follow-up (up to 5 years)
|
Time to Progression
Time Frame: From study registration to date of progression (up to 5 years)
|
Estimated using Kaplan-Meier survival curve.
Patients who died were considered to have disease progression at the time of death unless there was documented evidence that no progression occurred before death.
For patients with bidimensionally measurable disease (measurable disease), progression is defined as > 25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions.
For patients without bidimensionally measurable disease (evaluable disease), progression is defined as unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians or appearance of new lesions.
|
From study registration to date of progression (up to 5 years)
|
Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations
Time Frame: Assessed up to 5 years
|
Confidence intervals for the true proportion will be calculated using the exact binomial method. Measurable patients must achieve at least a 50% reduction in the product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose. Evaluable patients must achieve unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose. |
Assessed up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Recurrence
- Gliosarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Histone Deacetylase Inhibitors
- Bortezomib
- Vorinostat
Other Study ID Numbers
- NCI-2009-00668 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA025224 (U.S. NIH Grant/Contract)
- CDR0000590113
- NCCTG-N0779
- N0779 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Giant Cell Glioblastoma
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma | Recurrent Adult Brain Tumor | Adult Subependymal Giant...United States
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Giant Cell Glioblastoma | Adult Gliosarcoma | Recurrent Adult Brain TumorUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
NRG OncologyNational Cancer Institute (NCI); Radiation Therapy Oncology GroupActive, not recruitingAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States, Canada
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)CompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
-
National Cancer Institute (NCI)Radiation Therapy Oncology GroupCompletedAdult Giant Cell Glioblastoma | Adult Glioblastoma | Adult GliosarcomaUnited States
Clinical Trials on vorinostat
-
Peter MacCallum Cancer Centre, AustraliaGlaxoSmithKline; Merck Sharp & Dohme LLCTerminatedFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone LymphomaAustralia
-
Indiana University School of MedicineBayerCompletedMyelodysplastic Syndromes | Leukemia, Myeloid, Acute | Leukemia, Promyelocytic, AcuteUnited States
-
Armando Santoro, MDTerminatedSmall Cell Lung CancerItaly
-
The Methodist Hospital Research InstituteWithdrawnNon-Hodgkin Lymphoma
-
Merck Sharp & Dohme LLCCompleted
-
Groupe Francophone des MyelodysplasiesMerck Sharp & Dohme LLCTerminated
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed
-
Virginia Commonwealth UniversityWithdrawn
-
Fox Chase Cancer CenterNational Comprehensive Cancer NetworkCompletedLocally Advanced Non-small Cell Lung CancerUnited States
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedLymphoma | Leukemia | Small Intestine Cancer | Prostate Cancer | Unspecified Adult Solid Tumor, Protocol Specific | Multiple Myeloma and Plasma Cell NeoplasmUnited States