AzTrials
AzTrials

Anaplastic AstrocytomaPhase 1/2NCT01189266

Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma

A Phase 1/2 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma, run by National Cancer Institute (NCI) at 180 sites in 3 countries.

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 and to see how well it works when given together with radiation therapy followed by maintenance therapy with vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a brainstem tumor). Read more about this study

Who is it for?
Ages 37 months to 21 years
What is being tested?
3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
180 sitesin 3 countries
Study dates
9 Aug 2010to 30 Sep 2021
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 37 months to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons, are eligible without histologic confirmation; patients with brainstem tumors that do not meet these criteria or not considered to be typical intrinsic pontine gliomas will only be eligible if the tumors are biopsied and proven to be an anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, or anaplastic mixed glioma; patients with juvenile pilocytic astrocytoma, fibrillary astrocytoma, gangliogliomas, or other mixed gliomas without anaplasia are not eligible; patients with disseminated disease are not eligible, and magnetic resonance imaging (MRI) of spine must be performed if disseminated disease is suspected by the treating physician
  • Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients must not have received any prior treatment except dexamethasone and/or surgery
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL
  • Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
Show all 18Show fewer
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
  • 0.8 mg/dL (3 to < 6 years of age)
  • 1 mg/dL (6 to < 10 years of age)
  • 1.2 mg/dL (10 to < 13 years of age)
  • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
  • 1.7 mg/dL (male) or 1.4 mg/dL (female) (>= 16 years of age)
  • Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT (ALT) is 45 U/L
  • Serum albumin >= 2 g/dL
  • Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants (with the exception of valproic acid) and seizures are well controlled
  • Patients must be able to swallow capsules or liquids; patients dependent on nasogastric (NG) tube feeding are not permitted to receive protocol therapy
  • Enrollment must be no later than 28 days after the date of radiographic diagnosis or surgery, whichever is the later date

Who cannot join

  • Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Growth factors that support platelet or white cell number or function must not have been administered within the 7 days prior to enrollment
  • Patients who are currently receiving another investigational drug are not eligible
  • Patients who are currently receiving other anti-cancer agents are not eligible
  • Patients must not currently be receiving enzyme inducing anticonvulsants
  • Patients on valproic acid must discontinue valproic acid for at least 2 weeks before starting protocol therapy
Show all 10Show fewer
  • Patients receiving coumadin, heparin, low-molecular weight heparin, or any other anti-coagulants are not eligible for study entry
  • Patients receiving acetylsalicylic acid (ASA) (> 81 mg/day), non-steroidal anti-inflammatory drugs, clopidogrel (Plavix), dipyridamole (Persantine), or any other drug that inhibits platelet function are not eligible for study entry
  • Patients who have an uncontrolled infection are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Trial locations and contacts

180 sites in 3 countries.

180 sites in 3 countries

United States174 sites

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87102

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • C S Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia, 30322

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78411

  • Beaumont Hospital - Dearborn

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Helen DeVos Children's Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

  • Greenville Cancer Treatment Center

    Greenville, South Carolina, 29605

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Carolina Blood and Cancer Care Associates PA-Lancaster

    Lancaster, South Carolina, 29720

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Miller Children's and Women's Hospital Long Beach

    Long Beach, California, 90806

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

  • Valley Children's Hospital

    Madera, California, 93636

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Providence Hospital

    Mobile, Alabama, 36608

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • El Camino Hospital

    Mountain View, California, 94040

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • Children's Hospital of Orange County

    Orange, California, 92868

  • AdventHealth Orlando

    Orlando, Florida, 32803

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32806

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Nemours Children's Hospital

    Orlando, Florida, 32827

  • Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Lake Huron Medical Center

    Port Huron, Michigan, 48060

  • Legacy Emanuel Children's Hospital

    Portland, Oregon, 97227

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Kaiser Permanente - Sacramento

    Sacramento, California, 95825

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • Methodist Children's Hospital of South Texas

    San Antonio, Texas, 78229

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • UCSF Medical Center-Parnassus

    San Francisco, California, 94143

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Kaiser Permanente-San Rafael

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical PLLC

    Seattle, Washington, 98104

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Kaiser Permanente Washington

    Seattle, Washington, 98112

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122-4307

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology PS

    Spokane, Washington, 99218

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Cardinal Glennon Children's Medical Center

    St Louis, Missouri, 63104

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Saint Louis-Cape Girardeau CCOP

    St Louis, Missouri, 63141

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Kaiser Permanente-Stockton

    Stockton, California, 95210

  • Overlook Hospital

    Summit, New Jersey, 07902

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California, 95688

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • Wenatchee Valley Hospital and Clinics

    Wenatchee, Washington, 98801

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

  • Southeast Clinical Oncology Research Consortium NCORP

    Winston-Salem, North Carolina, 27104

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

Australia3 sites

  • Royal Children's Hospital-Brisbane

    Herston, Queensland, 4029

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6008

  • Queensland Children's Hospital

    South Brisbane, Queensland, 4101

Other trials in Australia

Canada3 sites

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: A Phase 1/2 Study of Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat) and Local Irradiation, Followed by Maintenance SAHA in Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas (DIPG)

This phase I/II trial studies the side effects and best dose of vorinostat and to see how well it works when given together with radiation therapy followed by maintenance therapy with vorinostat in treating younger patients with newly diagnosed diffuse intrinsic pontine glioma (a brainstem tumor). Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with radiation therapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the maximum tolerated dose (MTD) or recommend a phase 2 dose of vorinostat given concurrently with radiation in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).

II. To define and describe the toxicities of vorinostat given concurrently with radiation in children with newly diagnosed DIPG.

III. To determine, in the context of this phase I/II trial, the anti-tumor activity of combining vorinostat with radiation, followed by maintenance vorinostat for twelve courses, in children with newly diagnosed DIPG, as measured by 12-month event-free survival (EFS) and overall survival (OS).

IV. To determine the toxicities of vorinostat for 12 additional courses after completion of vorinostat and radiation.

SECONDARY OBJECTIVES:

  1. To measure non-homologous end-joining (NHEJ) activity in peripheral blood mononuclear cells (PBMCs) before treatment, at 2 weeks after starting vorinostat and radiation, and at the end of radiation.

II. To measure histone deacetylase 2 (HDAC2) levels and assess histone acetylation in PBMCs before treatment, at 2 weeks after starting vorinostat and radiation, and at the end of radiation.

III. To quantify deoxyribonucleic acid (DNA) repair proteins from the NHEJ and homologous recombination repair (HHR) pathways in tumors by either Western analysis or immunohistochemistry, if paraffin-embedded tumor is available.

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

Patients receive vorinostat orally (PO) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients undergo 3-dimensional (3D) conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. Patients then receive maintenance therapy comprising vorinostat PO on days 1-28. Treatment 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 at 3, 6, 9, 12, 18, 24, 36, 48, and 60 months.

Being tested
3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy, Laboratory Biomarker Analysis, Vorinostat
Medical subject headings
Astrocytoma, Diffuse Intrinsic Pontine Glioma, 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 3D conformal radiation therapy

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy

    Undergo intensity-modulated radiation therapy

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • VorinostatDrug

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

    Given PO

Study groups in NCT01189266
Study groupRoleWhat they receive
Arm 1 Phase I Vorinostat 180 mg/m^2ExperimentalPatients in phase I received vorinostat at 180 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment 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; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Drug: Vorinostat
Arm 2 Phase 1 Vorinostat 230 mg/m^2ExperimentalPatients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/day PO on days 1-28. Treatment 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; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Drug: Vorinostat
Arm 3 Phase II Evaluation Vorinostat 230 mg/m^2ExperimentalPatients received a higher dose of vorinostat at 230 mg/m^2/day PO on Monday through Friday weekly for the duration of radiation therapy (6-7 weeks). Patients underwent 3D conformal or intensity-modulated radiation therapy 5 days per week for 6 weeks. After completing concurrent vorinostat and radiation therapy, patients then received maintenance therapy comprising of vorinostat at 230 mg/m^2/ day PO on days 1-28. Treatment 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; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Drug: Vorinostat

What is being measured

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

  1. Maximum Tolerated Dose (MTD) of Vorinostat

    The dose of vorinostat in mg/sqm/day to be administered with combination chemotherapy and radiation therapy

    Measured: Planned 7 weeks during chemoradiotherapy

  2. Event-Free Survival

    Time from enrollment to disease progression, diagnosis of a second malignant neoplasm, death or last follow-up, whichever occurs first.

    Measured: 2 years after study enrollment

  3. Incidence of Toxicity During Chemoradiation Therapy

    Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience

    Measured: Planned 7 weeks during chemoradiotherapy

  4. Incidence of Toxicity During Maintenance Therapy

    Proportion of patients who experience any grade 3 or higher CTC AE Version 4 adverse experience

    Measured: Planned 12 months of maintenance with Vorinostat

Secondary outcomes (4)

  1. Overall Survival

    Time from enrollment to death or last follow-up, whichever occurs first.

    Measured: 2 years after study enrollment

  2. Change in H3 and H4 Acetylation Levels in PBMCs

    Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked.

    Measured: Baseline to up to 7 weeks

  3. Change in NHEJ Activity in PBMCs

    Descriptive statistics will be used to summarize the biological/laboratory measures and the changes in these measures across time-points.

    Measured: Baseline to up to 7 weeks

  4. Levels of DNA Repair Proteins in Paraffin-embedded Blocks, Measured Via Immunohistochemistry or Western Analysis

    For immunohistochemistry from tumor blocks, the intensity will be graded from 1 to 3; for Western analysis, a percentage of the intensity relative to the tumor with the highest level will be measured.

    Measured: Baseline

Timeline

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

  1. First posted26 Aug 2010 (estimated)
  2. Study start9 Aug 2010
  3. Primary completion30 Jun 2017
  4. Study completion30 Sep 2021

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
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01189266
Sponsor's protocol ID
NCI-2011-02600
Other IDs
NCI-2011-02600, ACNS0927, S12-02793, COG-ACNS0927, CDR0000683459, ACNS0927, ACNS0927, U10CA180886
Status last verified
Oct 2021
First submitted
25 Aug 2010
Last updated
28 Oct 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 3-Dimensional Conformal Radiation Therapy, Intensity-Modulated Radiation Therapy and Laboratory Biomarker Analysis in people with Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma, run by National Cancer Institute (NCI) at 180 sites in 3 countries.

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 18 inclusion and 10 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Australia, Canada. 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 3 Mar 2020). 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 (MTD) of Vorinostat (time frame: Planned 7 weeks during chemoradiotherapy). The study lists 4 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 NCT01189266.

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 28 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in