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Adult Giant Cell GlioblastomaPhase 1/2NCT00731731

Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase 1/2 study testing 3-Dimensional Conformal Radiation Therapy, Cognitive Assessment and Laboratory Biomarker Analysis in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 110 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This phase I/II trial studies the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-Dimensional Conformal Radiation Therapy, Cognitive Assessment and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
110 sitesUnited States
Study dates
10 Jul 2009to 1 Nov 2019
Phase
Phase 1/2
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

  • PRE-REGISTRATION:
  • Central pathology review submission; this review is mandatory prior to registration to confirm eligibility; it should be initiated as soon after surgery as possible
  • Treatment should begin >= 2 weeks and =< 5 weeks following surgery
  • REGISTRATION:
  • Histologically confirmed glioblastoma multiforme as determined by pre-registration central pathology review; Note: gliosarcomas and other grade 4 astrocytoma variants (e.g., giant cell) are eligible
  • Measurable or evaluable disease by gadolinium magnetic resonance imaging (MRI) or contrast computed tomography (CT) scan; Note: patients who have had a gross total resection (GTR) are eligible on the basis of evaluable disease
Show all 23Show fewer
  • Must begin partial brain radiotherapy on the same day that vorinostat and temozolomide begin
  • Karnofsky performance status of >= 60
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Absolute neutrophil count (ANC) >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • White blood cell (WBC) >= 3,000/mm^3
  • Hemoglobin >= 10.0 g/dL; Note: this level may be reached by transfusion
  • Total bilirubin =< 2.0 x institutional upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 2.0 x ULN
  • Creatinine =< 1.5 mg/dL
  • Life expectancy >= 12 weeks
  • Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • For Phase I established MTD and Phase II patients only: Willing and able to complete neurocognitive testing
  • Ability to provide informed written consent
  • Willing to return to Alliance or Adult Brain Tumor Consortium (ABTC) enrolling institution for follow-up
  • Phase I established MTD patients and Phase II patients: Willing to provide mandatory tissue samples (slides or blocks) for research purposes
  • Willing to forego other cytotoxic and non-cytotoxic drug therapy against the tumor while being treated with vorinostat and temozolomide

Who cannot join

  • Any of the following:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception throughout the duration of the study and for 12 weeks after treatment has ended
  • Prior cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy for brain tumors
  • Prior cranial RT
Show all 26Show fewer
  • Prior Gliadel wafers
  • Known hypersensitivity to any of the components of vorinostat or other agents used in study
  • Valproic acid, another histone deacetylase inhibitor, =< 2 weeks prior to registration and during treatment
  • Other active malignancy =< 3 years prior to registration; Exception: non-melanotic skin cancer or carcinoma in situ of the cervix; Note: if there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
  • Uncontrolled infection
  • Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy; Note: patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Co-morbid systemic illness or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with proper assessment of safety and adverse events of the prescribed regimens
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
  • History of myocardial infarction or unstable angina =< 6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • New York Heart Association (NYHA) >= Class II Congestive Heart Failure
  • Inability to take oral medications
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Congenital long QT syndrome
  • Prolonged corrected (QTc) interval (> 450 msec)
  • Any of the following Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes =< 7 days prior to registration
  • 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

Trial locations and contacts

110 sites in 1 country.

110 sites in 1 country

United States110 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Presence Resurrection Medical Center

    Chicago, Illinois, 60631

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    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

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • 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

  • Spector, David MD (UIA Investigator)

    Moline, Illinois, 61265

  • Stoffel, Thomas J MD (UIA Investigator)

    Moline, Illinois, 61265

  • Trinity Medical Center

    Moline, Illinois, 61265

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • Cancer Trials Support Unit

    Rockville, Maryland, 20850-2062

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Metro Minnesota Community Oncology Research Consortium

    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

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • UCSF Medical Center-Parnassus

    San Francisco, California, 94143

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67214

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]), Temozolomide, and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma

This phase I/II trial studies the side effects and best dose of vorinostat when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with temozolomide and radiation therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose (MTD) of vorinostat in patients with newly diagnosed glioblastoma multiforme (GBM) and gliosarcomas, who are also receiving concomitant radiation therapy (RT) and temozolomide (TMZ). (Phase I) II. To define the safety of vorinostat with RT and TMZ in this population. (Phase II) III. To determine the efficacy of vorinostat in combination with RT and TMZ followed by vorinostat in combination with TMZ in patients with newly-diagnosed GBM and gliosarcomas as measured by overall survival at 15 months (OS15). (Phase II)

SECONDARY OBJECTIVES:

  1. To determine progression-free survival in newly diagnosed GBM and gliosarcoma patients treated with the study regimen. (Phase II) II. To further evaluate the safety profile of vorinostat in combination with RT and TMZ in this patient population. (Phase II) III. Determine the neurocognitive effects in patients treated on this protocol and correlate these results with outcome endpoints. (Phase II)

TERTIARY OBJECTIVES:

  1. To explore the extent to which the tumor's molecular characteristics and expression profile correlate with outcome.

II. Evaluate potential mechanisms of therapy resistance in tumor samples obtained at the time of tumor progression.

OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II study.

Patients undergo radiotherapy and receive vorinostat orally (PO) once daily (QD) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive vorinostat PO QD on days 1-7 and 15-21 and temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months for 1 year and then every 6 months for 3 years.

Being tested
3-Dimensional Conformal Radiation Therapy, Cognitive Assessment, Laboratory Biomarker Analysis, Temozolomide, Vorinostat
Medical subject headings
Glioblastoma, Gliosarcoma

What participants receive

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

  • 3-Dimensional Conformal Radiation TherapyRadiation

    Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT

    Undergo radiotherapy

  • Cognitive AssessmentProcedure or surgery

    Ancillary studies

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • TemozolomideDrug

    Also called CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831

    Given PO

  • VorinostatDrug

    Also called L-001079038, MSK-390, SAHA, Suberanilohydroxamic Acid

    Given PO

Study groups in NCT00731731
Study groupRoleWhat they receive
Treatment (radiation therapy, vorinostat, temozolomide)ExperimentalPatients undergo radiotherapy and receive vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive vorinostat PO QD on days 1-7 and 15-21 and temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Cognitive Assessment; Other: Laboratory Biomarker Analysis; Drug: Temozolomide; Drug: Vorinostat

What is being measured

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

  1. Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)

    The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.

    >

    >

    DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:

    • Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days
    • Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism
    • Grade 4 radiation-induced skin changes
    • Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs

    Measured: 10 weeks

  2. Overall Survival at 15 Months (Phase II)

    The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.

    Measured: Time from study registration to the date of death from any cause, assessed up to 5 years

Secondary outcomes (3)

  1. Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade

    Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.

    Measured: Up to 5 years

  2. Time to Tumor Progression (Phase II)

    Progression free survival time will be defined from date of registration to date of progression or death.

    Measured: Up to 5 years

  3. Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)

    The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing.

    Measured: 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 posted11 Aug 2008 (estimated)
  2. Study start10 Jul 2009
  3. Primary completion2 Feb 2014
  4. Study completion1 Nov 2019

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00731731
Sponsor's protocol ID
NCI-2009-00672
Other IDs
NCI-2009-00672, N0874, ABTC 0902, CDR0000609743, N0874, N0874, U10CA180821, U10CA025224
Status last verified
Aug 2022
First submitted
8 Aug 2008
Last updated
4 Aug 2022
Data monitoring committee
Yes

Publications

  • Cerhan JH, Anderson SK, Butts AM, Porter AB, Jaeckle K, Galanis E, Brown PD. Examiner accuracy in cognitive testing in multisite brain-tumor clinical trials: an analysis from the Alliance for Clinical Trials in Oncology. Neurooncol Pract. 2019 Jul;6(4):283-288. doi: 10.1093/nop/npy048. Epub 2018 Nov 24.

    PubMed 31386061

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 3-Dimensional Conformal Radiation Therapy, Cognitive Assessment and Laboratory Biomarker Analysis in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by National Cancer Institute (NCI) at 110 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 23 inclusion and 26 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 13 May 2015). 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?

Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I) (time frame: 10 weeks). The study lists 2 primary outcomes in all. 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 NCT00731731, which also lists 1 linked publication.

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 4 Aug 2022.

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