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AzTrials

Adult Giant Cell GlioblastomaPhase 2NCT00641706

Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme

A Phase 2 study testing vorinostat, therapeutic conventional surgery and bortezomib in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 214 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vorinostat, therapeutic conventional surgery and bortezomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
214 sitesUnited States
Study dates
Jul 2008to Nov 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 53Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

214 sites in 1 country.

214 sites in 1 country

United States214 sites

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Saint Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies PC

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61701

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Memorial Hospital

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cedar Rapids Oncology Association

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • North Coast Cancer Care-Clyde

    Clyde, Ohio, 43410

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-2001

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton CCOP

    Dayton, Ohio, 45420

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Exempla Saint Joseph Hospital

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program CCOP

    Denver, Colorado, 80224-2522

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Essentia Health Duluth Clinic CCOP

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Midelfort Clinic-Clairemont Campus

    Eau Claire, Wisconsin, 54702

  • Mayo Clinic Health System Eau Claire Hospital - Luther Campus

    Eau Claire, Wisconsin, 54703

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Sanford Medical Center-Fargo

    Fargo, North Dakota, 58122

  • Lake Region Healthcare Corporation-Cancer Care

    Fergus Falls, Minnesota, 56537

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Agnesian Cancer Center

    Fond du Lac, Wisconsin, 54935

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare Galesburg

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Cottage

    Galesburg, Illinois, 61401

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81502

  • Grand Rapids Clinical Oncology Program

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Illinois CancerCare-Havana

    Havana, Illinois, 62644

  • Mason District Hospital

    Havana, Illinois, 62644

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • McKee Medical Center

    Loveland, Colorado, 80539

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Saint Luke's Hospital

    Maumee, Ohio, 43537

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center

    Maumee, Ohio, 43537

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545-1470

  • Community Medical Hospital

    Missoula, Montana, 59801

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Garneau, Stewart C MD (UIA Investigator)

    Moline, Illinois, 61265

  • Porubcin, Michael MD (UIA Investigator)

    Moline, Illinois, 61265

  • Sharis, Christine M MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Holy Family Medical Center

    Monmouth, Illinois, 61462

  • Illinois CancerCare-Monmouth

    Monmouth, Illinois, 61462

  • Community Cancer Center of Monroe

    Monroe, Michigan, 48162

  • Mercy Memorial Hospital

    Monroe, Michigan, 48162

  • Mercy Health Partners-Hackley Campus

    Muskegon, Michigan, 49442

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Illinois CancerCare-Community Cancer Center

    Normal, Illinois, 61761

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers-Oregon

    Oregon, Ohio, 43616

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61603

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61603

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Illinois Oncology Research Association CCOP

    Peoria, Illinois, 61615

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Metro-Minnesota CCOP

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Upstate Carolina CCOP

    Spartanburg, South Carolina, 29303

  • Illinois CancerCare-Spring Valley

    Spring Valley, Illinois, 61362

  • Saint Margaret's Hospital

    Spring Valley, Illinois, 61362

  • Geisinger Medical Group

    State College, Pennsylvania, 16801

  • Flower Hospital

    Sylvania, Ohio, 43560

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Toledo Community Hospital Oncology Program CCOP

    Toledo, Ohio, 43617

  • Mercy Saint Anne Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Upper Valley Medical Center

    Troy, Ohio, 45373

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Carle Clinic-Urbana Main

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Saint Ann's Hospital

    Westerville, Ohio, 43081

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Geisinger Wyoming Valley

    Wilkes-Barre, Pennsylvania, 18711

  • Clinton Memorial Hospital

    Wilmington, Ohio, 45177

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Metro Health Hospital

    Wyoming, Michigan, 49519

  • Greene Memorial Hospital

    Xenia, Ohio, 45385

  • Genesis HealthCare System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Phase II Study of Vorinostat (SAHA) in Combination With Bortezomib (PS-341) in Patients With Recurrent Glioblastoma Multiforme

This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with progressive, recurrent glioblastoma multiforme. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Medical subject headings
Glioblastoma, Gliosarcoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00641706
Study groupRoleWhat they receive
Stratum 1 (not undergoing surgery)ExperimentalPatients 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.
Receives: Drug: vorinostat; Drug: bortezomib
Stratum 2 (undergoing surgery)ExperimentalPatients 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.
Receives: Drug: vorinostat; Procedure: therapeutic conventional surgery; Drug: bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival 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.

    Measured: At 6 months

Secondary outcomes (3)

  1. Overall Survival

    Estimated using Kaplan-Meier survival curve.

    Measured: From study registration to date of death due to any cause or last follow-up (up to 5 years)

  2. Time to Progression

    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.

    Measured: From study registration to date of progression (up to 5 years)

  3. Proportion of Confirmed Tumor Response Defined as an Objective Status of Confirmed Response (CR), Partial Response (PR), or Regression (REGR) on Two Consecutive Evaluations

    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.

    Measured: Assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00641706
Sponsor's protocol ID
NCI-2009-00668
Other IDs
NCI-2009-00668, CDR0000590113, NCCTG-N0779, N0779, N0779, U10CA025224
Status last verified
Oct 2011
First submitted
21 Mar 2008
Last updated
14 May 2014

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vorinostat, therapeutic conventional surgery and bortezomib in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 214 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 53 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival at 6 Months (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00641706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.

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