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Vorinostat and Radiation Therapy Followed by Maintenance Therapy With Vorinostat in Treating Younger Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01189266
First received: August 25, 2010
Last updated: September 13, 2017
Last verified: May 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Anaplastic Astrocytoma Anaplastic Oligoastrocytoma Brain Stem Glioma Childhood Glioblastoma Giant Cell Glioblastoma Gliosarcoma Untreated Childhood Anaplastic Astrocytoma Untreated Childhood Anaplastic Oligoastrocytoma Untreated Childhood Brain Stem Glioma Untreated Childhood Giant Cell Glioblastoma Untreated Childhood Gliosarcoma | Radiation: 3-Dimensional Conformal Radiation Therapy Radiation: Intensity-Modulated Radiation Therapy Other: Laboratory Biomarker Analysis Drug: Vorinostat | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Drug Information available for:
Vorinostat
Genetic and Rare Diseases Information Center resources:
Glioblastoma
Glioma
Gliosarcoma
Childhood Brain Stem Glioma
Anaplastic Astrocytoma
Diffuse Intrinsic Pontine Glioma
Oligoastrocytoma
Anaplastic Oligoastrocytoma
Oligodendroglioma
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- EFS (Phase II) [ Time Frame: Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, or date of last follow-up measured from time of study enrollment, assessed up to 60 months ]Mean and standard deviation will be used to summarize continuous measures; log transformation may be considered when appropriate. Log rank tests will be used to explore the prognostic significance of a categorical factor on EFS. Cox proportional hazards models will be used to explore the effect of a continuous marker on EFS, and will be used for exploratory multivariate analysis examining the effect of the predictor of interest with adjustments for other patient characteristics or risk factors.
- Incidence of toxicities (Phase II) [ Time Frame: Up to 60 months ]The analysis of toxicity will focus on estimates of the rates of chemoradiotherapy-phase DLT and rates of maintenance phase toxicities. Estimates will be obtained using life-table methods, with an event defined as the first occurrence of a primary toxicity. Patients who have progression or recurrence of disease will be censored in these analyses. Appropriate adjustment will be made to the rates estimates to account for potential effects of the initial vorinostat dose selection. Categorical measures will be described by percentages with binary confidence intervals and frequency tables.
- MTD of vorinostat, defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) during chemoradiation, graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) (Phase I) [ Time Frame: Up to 7 weeks ]Categorical measures will be described by percentages with binary confidence intervals and frequency tables.
Secondary Outcome Measures:
- Change in H3 and H4 acetylation levels in PBMCs [ Time Frame: Baseline to up to 7 weeks ]Degree of acetylation in peripheral blood monocytes will be divided into quartiles and coded as none, mild, moderation or marked. Descriptive statistics will be used to summarize the biological/laboratory measures and the changes in these measures across time-points. Exploratory analyses to correlate the biological/laboratory measures with disease outcome will be performed.
- Change in NHEJ activity in PBMCs [ Time Frame: Baseline to up to 7 weeks ]Descriptive statistics will be used to summarize the biological/laboratory measures and the changes in these measures across time-points. Exploratory analyses to correlate the biological/laboratory measures with disease outcome will be performed.
- Levels of DNA repair proteins in paraffin-embedded blocks, measured via immunohistochemistry or Western analysis [ Time Frame: Baseline ]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. Descriptive statistics will be used to summarize the biological/laboratory measures. Exploratory analyses to correlate the biological/laboratory measures with disease outcome will be performed.
- OS (Phase II) [ Time Frame: Time to death from any cause, assessed up to 60 months ]Mean and standard deviation will be used to summarize continuous measures; log transformation may be considered when appropriate. Log rank tests will be used to explore the prognostic significance of a categorical factor on OS. Cox proportional hazards models will be used to explore the effect of a continuous marker on OS, and will be used for exploratory multivariate analysis examining the effect of the predictor of interest with adjustments for other patient characteristics or risk factors.
| Estimated Enrollment: | 80 |
| Actual Study Start Date: | August 9, 2010 |
| Estimated Primary Completion Date: | November 30, 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1 Phase I Vorinostat 180 mg/m^2
Patients in phase I receive vorinostat PO on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients undergo 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. Interventions: |
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D conformal radiation therapy
Other Names:
Radiation: Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Vorinostat
Given PO
Other Names:
|
|
Experimental: Arm 2 Phase 1 Virinostat 230 mg/m^2
Patients receive a higher dose of vorinostat PO on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients undergo 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. Interventions: |
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D conformal radiation therapy
Other Names:
Radiation: Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Vorinostat
Given PO
Other Names:
|
|
Experimental: Arm 3 Phase II Evaluation Virinostat 230 mg/m^2
Patients in phase II receive vorinostat PO on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients undergo 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.
|
Radiation: 3-Dimensional Conformal Radiation Therapy
Undergo 3D conformal radiation therapy
Other Names:
Radiation: Intensity-Modulated Radiation Therapy
Undergo intensity-modulated radiation therapy
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
|
Detailed Description:
PRIMARY OBJECTIVES:
l. 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:
I. 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.
Eligibility| Ages Eligible for Study: | 37 Months to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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)
-
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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01189266
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01189266
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Locations
| United States, Alabama | |
| Children's Hospital of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| University of Alabama at Birmingham Cancer Center | |
| Birmingham, Alabama, United States, 35233 | |
| Providence Hospital | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| Highlands Oncology Group-Rogers | |
| Rogers, Arkansas, United States, 72758 | |
| United States, California | |
| Kaiser Permanente-Deer Valley Medical Center | |
| Antioch, California, United States, 94531 | |
| Southern California Permanente Medical Group | |
| Downey, California, United States, 90242 | |
| Kaiser Permanente-Fremont | |
| Fremont, California, United States, 94538 | |
| Kaiser Permanente | |
| Fresno, California, United States, 93720 | |
| Miller Children's and Women's Hospital Long Beach | |
| Long Beach, California, United States, 90806 | |
| Cedars Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Children's Hospital Central California | |
| Madera, California, United States, 93636-8762 | |
| Contra Costa Regional Medical Center | |
| Martinez, California, United States, 94553-3156 | |
| El Camino Hospital | |
| Mountain View, California, United States, 94040 | |
| Highland General Hospital | |
| Oakland, California, United States, 94602 | |
| Children's Hospital and Research Center at Oakland | |
| Oakland, California, United States, 94609-1809 | |
| Alta Bates Summit Medical Center - Summit Campus | |
| Oakland, California, United States, 94609 | |
| Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| Kaiser Permanente-Oakland | |
| Oakland, California, United States, 94611 | |
| Children's Hospital of Orange County | |
| Orange, California, United States, 92868 | |
| Kaiser Permanente-Redwood City | |
| Redwood City, California, United States, 94063 | |
| Kaiser Permanente-Richmond | |
| Richmond, California, United States, 94801 | |
| Kaiser Permanente-Roseville | |
| Roseville, California, United States, 95661 | |
| Kaiser Permanente-South Sacramento | |
| Sacramento, California, United States, 95823 | |
| Kaiser Permanente - Sacramento | |
| Sacramento, California, United States, 95825 | |
| Rady Children's Hospital - San Diego | |
| San Diego, California, United States, 92123 | |
| Kaiser Permanente-San Francisco | |
| San Francisco, California, United States, 94115 | |
| UCSF Medical Center-Parnassus | |
| San Francisco, California, United States, 94143 | |
| Kaiser Permanente-Santa Teresa-San Jose | |
| San Jose, California, United States, 95119 | |
| Kaiser Permanente San Leandro | |
| San Leandro, California, United States, 94577 | |
| Doctors Medical Center- JC Robinson Regional Cancer Center | |
| San Pablo, California, United States, 94806 | |
| Kaiser Permanente-San Rafael | |
| San Rafael, California, United States, 94903 | |
| Kaiser Permanente Medical Center - Santa Clara | |
| Santa Clara, California, United States, 95051 | |
| Kaiser Permanente-Santa Rosa | |
| Santa Rosa, California, United States, 95403 | |
| Kaiser Permanente-South San Francisco | |
| South San Francisco, California, United States, 94080 | |
| Kaiser Permanente-Stockton | |
| Stockton, California, United States, 95210 | |
| Kaiser Permanente Medical Center-Vacaville | |
| Vacaville, California, United States, 95688 | |
| Kaiser Permanente-Vallejo | |
| Vallejo, California, United States, 94589 | |
| Kaiser Permanente-Walnut Creek | |
| Walnut Creek, California, United States, 94596 | |
| United States, Colorado | |
| Children's Hospital Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Smilow Cancer Hospital Care Center at Saint Francis | |
| Hartford, Connecticut, United States, 06105 | |
| United States, Delaware | |
| Alfred I duPont Hospital for Children | |
| Wilmington, Delaware, United States, 19803 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, D.C., District of Columbia, United States, 20010 | |
| United States, Florida | |
| Lee Memorial Health System | |
| Fort Myers, Florida, United States, 33901 | |
| Golisano Children's Hospital of Southwest Florida | |
| Fort Myers, Florida, United States, 33908 | |
| Nemours Children's Clinic-Jacksonville | |
| Jacksonville, Florida, United States, 32207 | |
| Florida Hospital Orlando | |
| Orlando, Florida, United States, 32803 | |
| Nemours Children's Clinic - Orlando | |
| Orlando, Florida, United States, 32806 | |
| UF Cancer Center at Orlando Health | |
| Orlando, Florida, United States, 32806 | |
| Nemours Children's Hospital | |
| Orlando, Florida, United States, 32827 | |
| Nemours Children's Clinic - Pensacola | |
| Pensacola, Florida, United States, 32504 | |
| Johns Hopkins All Children's Hospital | |
| Saint Petersburg, Florida, United States, 33701 | |
| United States, Georgia | |
| Children's Healthcare of Atlanta - Egleston | |
| Atlanta, Georgia, United States, 30322 | |
| Memorial University Medical Center | |
| Savannah, Georgia, United States, 31404 | |
| United States, Hawaii | |
| University of Hawaii Cancer Center | |
| Honolulu, Hawaii, United States, 96813 | |
| Kaiser Permanente Moanalua Medical Center | |
| Honolulu, Hawaii, United States, 96819 | |
| United States, Idaho | |
| Saint Alphonsus Cancer Care Center-Boise | |
| Boise, Idaho, United States, 83706 | |
| United States, Illinois | |
| Saint Anthony's Health | |
| Alton, Illinois, United States, 62002 | |
| Decatur Memorial Hospital | |
| Decatur, Illinois, United States, 62526 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Good Samaritan Regional Health Center | |
| Mount Vernon, Illinois, United States, 62864 | |
| Edward Hospital/Cancer Center | |
| Naperville, Illinois, United States, 60540 | |
| Saint Jude Midwest Affiliate | |
| Peoria, Illinois, United States, 61637 | |
| Memorial Medical Center | |
| Springfield, Illinois, United States, 62781 | |
| United States, Indiana | |
| Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| Blank Children's Hospital | |
| Des Moines, Iowa, United States, 50309 | |
| United States, Kentucky | |
| Baptist Health Lexington | |
| Lexington, Kentucky, United States, 40503 | |
| University of Kentucky/Markey Cancer Center | |
| Lexington, Kentucky, United States, 40536 | |
| Norton Children's Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| Saint Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Michigan Cancer Research Consortium NCORP | |
| Ann Arbor, Michigan, United States, 48106 | |
| C S Mott Children's Hospital | |
| Ann Arbor, Michigan, United States, 48109 | |
| Beaumont Hospital-Dearborn | |
| Dearborn, Michigan, United States, 48124 | |
| Saint John Hospital and Medical Center | |
| Detroit, Michigan, United States, 48236 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48502 | |
| Genesys Regional Medical Center-West Flint Campus | |
| Flint, Michigan, United States, 48532 | |
| Helen DeVos Children's Hospital at Spectrum Health | |
| Grand Rapids, Michigan, United States, 49503 | |
| Allegiance Health | |
| Jackson, Michigan, United States, 49201 | |
| Sparrow Hospital | |
| Lansing, Michigan, United States, 48912 | |
| Saint Mary Mercy Hospital | |
| Livonia, Michigan, United States, 48154 | |
| Saint Joseph Mercy Oakland | |
| Pontiac, Michigan, United States, 48341 | |
| Lake Huron Medical Center | |
| Port Huron, Michigan, United States, 48060 | |
| Saint Mary's of Michigan | |
| Saginaw, Michigan, United States, 48601 | |
| Saint John Macomb-Oakland Hospital | |
| Warren, Michigan, United States, 48093 | |
| United States, Minnesota | |
| University of Minnesota/Masonic Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| Singing River Hospital | |
| Pascagoula, Mississippi, United States, 39581 | |
| United States, Missouri | |
| Saint Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63703 | |
| The Childrens Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Cardinal Glennon Children's Medical Center | |
| Saint Louis, Missouri, United States, 63104 | |
| Saint Louis Cancer and Breast Institute-South City | |
| Saint Louis, Missouri, United States, 63109 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| Saint Louis-Cape Girardeau CCOP | |
| Saint Louis, Missouri, United States, 63141 | |
| Cancer Research for the Ozarks NCORP | |
| Springfield, Missouri, United States, 65804 | |
| Mercy Hospital Springfield | |
| Springfield, Missouri, United States, 65804 | |
| CoxHealth South Hospital | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59101 | |
| Saint Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| Montana Cancer Consortium NCORP | |
| Billings, Montana, United States, 59102 | |
| Saint Vincent Frontier Cancer Center | |
| Billings, Montana, United States, 59102 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| Benefis Healthcare- Sletten Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| Saint Peter's Community Hospital | |
| Helena, Montana, United States, 59601 | |
| Glacier Oncology PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Saint Patrick Hospital - Community Hospital | |
| Missoula, Montana, United States, 59802 | |
| United States, Nebraska | |
| CHI Health Good Samaritan | |
| Kearney, Nebraska, United States, 68847 | |
| United States, New Jersey | |
| Morristown Medical Center | |
| Morristown, New Jersey, United States, 07960 | |
| Saint Peter's University Hospital | |
| New Brunswick, New Jersey, United States, 08901 | |
| Newark Beth Israel Medical Center | |
| Newark, New Jersey, United States, 07112 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07902 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | |
| New York, New York, United States, 10016 | |
| Columbia University/Herbert Irving Cancer Center | |
| New York, New York, United States, 10032 | |
| Montefiore Medical Center - Moses Campus | |
| The Bronx, New York, United States, 10467-2490 | |
| United States, North Carolina | |
| Mission Hospital-Memorial Campus | |
| Asheville, North Carolina, United States, 28801 | |
| Carolinas Medical Center/Levine Cancer Institute | |
| Charlotte, North Carolina, United States, 28203 | |
| Wayne Memorial Hospital | |
| Goldsboro, North Carolina, United States, 27534 | |
| Margaret R Pardee Memorial Hospital | |
| Hendersonville, North Carolina, United States, 28791 | |
| Iredell Memorial Hospital | |
| Statesville, North Carolina, United States, 28677 | |
| Southeast Clinical Oncology Research (SCOR) Consortium NCORP | |
| Winston-Salem, North Carolina, United States, 27104 | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Akron General Medical Center | |
| Akron, Ohio, United States, 44307 | |
| Children's Hospital Medical Center of Akron | |
| Akron, Ohio, United States, 44308 | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Oregon | |
| Saint Charles Health System | |
| Bend, Oregon, United States, 97701 | |
| Legacy Emanuel Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Penn State Children's Hospital | |
| Hershey, Pennsylvania, United States, 17033 | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| AnMed Health Hospital | |
| Anderson, South Carolina, United States, 29621 | |
| Palmetto Health Richland | |
| Columbia, South Carolina, United States, 29203 | |
| Saint Francis Hospital | |
| Greenville, South Carolina, United States, 29601 | |
| BI-LO Charities Children's Cancer Center | |
| Greenville, South Carolina, United States, 29605 | |
| Greenville Cancer Treatment Center | |
| Greenville, South Carolina, United States, 29605 | |
| Carolina Blood and Cancer Care Associates PA-Lancaster | |
| Lancaster, South Carolina, United States, 29720 | |
| Spartanburg Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Vanderbilt University/Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Driscoll Children's Hospital | |
| Corpus Christi, Texas, United States, 78411 | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Methodist Children's Hospital of South Texas | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Primary Children's Hospital | |
| Salt Lake City, Utah, United States, 84113 | |
| United States, Virginia | |
| Childrens Hospital-King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Cancer Care Center at Island Hospital | |
| Anacortes, Washington, United States, 98221 | |
| PeaceHealth Saint Joseph Medical Center | |
| Bellingham, Washington, United States, 98225 | |
| Harrison HealthPartners Hematology and Oncology-Bremerton | |
| Bremerton, Washington, United States, 98310 | |
| Highline Medical Center-Main Campus | |
| Burien, Washington, United States, 98166 | |
| Kadlec Clinic Hematology and Oncology | |
| Kennewick, Washington, United States, 99336 | |
| Skagit Valley Hospital | |
| Mount Vernon, Washington, United States, 98274 | |
| Harrison HealthPartners Hematology and Oncology-Poulsbo | |
| Poulsbo, Washington, United States, 98370 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Minor and James Medical PLLC | |
| Seattle, Washington, United States, 98104 | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98105 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
| Kaiser Permanente Washington | |
| Seattle, Washington, United States, 98112 | |
| Swedish Medical Center-First Hill | |
| Seattle, Washington, United States, 98122-4307 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| United General Hospital | |
| Sedro-Woolley, Washington, United States, 98284 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Evergreen Hematology and Oncology PS | |
| Spokane, Washington, United States, 99218 | |
| Mary Bridge Children's Hospital and Health Center | |
| Tacoma, Washington, United States, 98405 | |
| Wenatchee Valley Hospital and Clinics | |
| Wenatchee, Washington, United States, 98801 | |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | |
| Yakima, Washington, United States, 98902 | |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| United States, Wyoming | |
| Welch Cancer Center | |
| Sheridan, Wyoming, United States, 82801 | |
| Australia, Queensland | |
| Royal Children's Hospital-Brisbane | |
| Herston, Queensland, Australia, 4029 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | |
| Perth, Western Australia, Australia, 6008 | |
| Canada, Ontario | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Centre Hospitalier Universitaire Sainte-Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Jack Su | Children's Oncology Group |
More Information
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01189266 History of Changes |
| Other Study ID Numbers: |
NCI-2011-02600 NCI-2011-02600 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000683459 COG-ACNS0927 ACNS0927 ACNS0927 ( Other Identifier: Childrens Oncology Group ) ACNS0927 ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) U10CA098543 ( U.S. NIH Grant/Contract ) UM1CA097452 ( U.S. NIH Grant/Contract ) |
| Study First Received: | August 25, 2010 |
| Last Updated: | September 13, 2017 |
Additional relevant MeSH terms:
|
Glioblastoma Glioma Astrocytoma Gliosarcoma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Vorinostat Antineoplastic Agents Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 19, 2017