Trial record 1 of 1 for:    ACNS0821
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Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors

This study is currently recruiting participants.
Verified September 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01217437
First received: October 7, 2010
Last updated: March 5, 2014
Last verified: September 2013
  Purpose

This randomized phase II trial is studying how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.


Condition Intervention Phase
Recurrent Childhood Medulloblastoma
Recurrent Childhood Pineoblastoma
Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
Drug: temozolomide
Drug: irinotecan hydrochloride
Biological: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, a COG Randomized Phase II Screening Trial

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival for each treatment arm [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Determined for each patient and compared across regimens using the log-rank test.


Secondary Outcome Measures:
  • Response rate for each treatment arm [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Compared by means of the exact conditional test of proportions.

  • Event-free survival [ Time Frame: From enrollment to disease progression, second malignant neoplasm, death regardless of cause, or date of last contact, whichever comes first, up to 5 years ] [ Designated as safety issue: No ]
    Estimated by Kaplan-Meier method. Determined for each patient and compared across regimens using the log-rank test.


Estimated Enrollment: 120
Study Start Date: November 2010
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (temozolomide, irinotecan hydrochloride)
Patients receive temozolomide PO and irinotecan hydrochloride IV over 90 minutes on days 1-5.
Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Experimental: Arm II (temozolomide, irinotecan hydrochloride, bevacizumab)
Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
Drug: temozolomide
Given PO
Other Names:
  • SCH 52365
  • Temodal
  • Temodar
  • TMZ
Drug: irinotecan hydrochloride
Given IV
Other Names:
  • Campto
  • Camptosar
  • CPT-11
  • irinotecan
  • U-101440E
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF

Detailed Description:

PRIMARY OBJECTIVES:

l. To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan (irinotecan hydrochloride), and bevacizumab for recurrent medulloblastoma (MB)/primitive neuroectodermal tumor (PNET) of childhood.

SECONDARY OBJECTIVES:

I. To assess the response rate for each treatment arm. II. To determine event-free survival (EFS) for each patient compared across regimens.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive temozolomide orally (PO) and irinotecan hydrochloride IV over 90 minutes on days 1-5.

ARM II: Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.

In both arms, 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 for 5 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy; patients with pineoblastoma are eligible
  • Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence
  • Patients must have measurable residual disease, defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI); diffuse leptomeningeal disease is not considered measurable
  • All patients must have a brain MRI with and without gadolinium and a spine MRI with gadolinium performed within 2 weeks prior to study enrollment
  • Patients must have a Lansky or Karnofsky performance status score of >= 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2 (use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age)
  • Patients must have a life expectancy of >= 8 weeks
  • Patients must have experienced at least one and at most two relapses prior to study enrollment; patients with primary refractory disease are eligible
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

    • Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea)
    • Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; at least 3 weeks for biologic agents with a long half life, such as antibodies
    • External beam radiation therapy (XRT): Must not have received craniospinal radiotherapy within 24 weeks prior to study entry; the tumor designated as "measurable" for protocol purposes must not have received radiation within 12 weeks prior to study entry); focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry
    • Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed prior to study entry
    • Study specific limitations on prior therapy:

      • Patients must not have previously received bevacizumab, irinotecan, temozolomide or other anti-vascular endothelial growth factor (VEGF) inhibitor
      • Patients must not be taking enzyme-inducing antiepileptic medicines within 1 week of study entry
  • Patients must have recovered from any surgical procedure before enrolling on this study:

    • Patients with a major surgical procedure within 28 days prior to enrollment should be excluded
    • Patients with an intermediate surgical procedure within 14 days prior to enrollment should be excluded
    • For minor surgical procedures (including Broviac line or infusaport placement), patients should not receive the first planned dose of bevacizumab until the wound is healed and at least 7 days have elapsed
    • There should be no anticipation of need for major surgical procedures during the course of the study

      • Examples of major, intermediate, or minor surgical procedures:

        • Major procedures: Major craniotomy for tumor resection; organ resection; bowel wall anastomosis; arteriovenous grafts; exploratory laparotomy; thoracotomy
        • Intermediate procedures: Ventriculoperitoneal (VP)-shunt placement; stereotactic brain biopsy
        • Minor procedures: Incision and drainage of superficial skin abscesses; punch biopsy of skin lesions; superficial skin wound suturing; bone marrow aspirate and/or biopsy; fine needle aspirations; Broviac line or infusaport placement; paracentesis or thoracocentesis
    • Please note: Lumbar punctures or placement of peripherally inserted central catheter (PICC) lines are not considered minor procedures and may occur at any time prior to or during therapy
  • Hypertension must be well controlled (=< 95th percentile for age and height if patient is =< 17 years) on stable doses of medication
  • Concomitant medications restrictions:

    • Growth factor(s): Must not have received within 7 days of entry onto this study
    • Steroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days
    • Study Specific: Patients must not be currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy > 81 mg/day
  • Peripheral absolute neutrophil count (ANC) >= 1000/uL (must not have received filgrastim [G-CSF] within the prior 7 days)
  • Platelet count >= 100,000/uL (transfusion independent)
  • Hemoglobin >= 8.0 gm/dL (may receive packed red blood cell [PRBC] transfusions)
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR a serum creatinine based on age/gender as follows:

    • =< 0.4 mg/dL (for patients aged 1 month to < 6 months)
    • =< 0.5 mg/dL (for patients aged 6 months to < 1 year)
    • =< 0.6 mg/dL (for patients aged 1 to < 2 years)
    • =< 0.8 mg/dL (for patients aged 2 to < 6 years)
    • =< 1 mg/dL (for patients aged 6 to < 10 years)
    • =< 1.2 mg/dL (for patients aged 10 to < 13 years)
    • =< 1.4 mg/dL (for female patients aged >= 13 years)
    • =< 1.5 mg/dL (for male patients aged 13 to < 16 years)
    • =< 1.7 mg/dL (for male patients aged >= 16 years)
  • Urine protein should be screened by dipstick analysis; if protein >= 2+ on dipstick, then urine protein creatinine (UPC) ratio should be calculated; if UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg/24 hours for patient enrollment
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) for age
  • Central nervous system function defined as

    • Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants
  • Adequate coagulation defined as

    • International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x upper limit of normal

Exclusion Criteria:

  • Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible for this study
  • Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry
  • Patients must not have a known bleeding diathesis or coagulopathy
  • Patients must not have had significant vascular disease (eg, aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study entry
  • Patients must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome); testing is not required in patients without thrombophilic history
  • Patients must not have evidence of new CNS hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
  • Patients with a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months are not eligible
  • Patients must not have serious and inadequately controlled cardiac arrhythmia
  • Female patients who are pregnant are not eligible for this study
  • Female patients who are breastfeeding are not eligible for this study unless they agree not to breastfeed
  • Female patients of childbearing potential must have a negative pregnancy test
  • Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217437

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Active, not recruiting
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
United States, Arizona
Phoenix Childrens Hospital Active, not recruiting
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Children's Hospital Active, not recruiting
Little Rock, Arkansas, United States, 72202-3591
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Active, not recruiting
Downey, California, United States, 90242
Loma Linda University Medical Center Active, not recruiting
Loma Linda, California, United States, 92354
Miller Children's Hospital Active, not recruiting
Long Beach, California, United States, 90806
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Cedars-Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
Children's Hospital Central California Active, not recruiting
Madera, California, United States, 93636-8762
Kaiser Permanente-Oakland Active, not recruiting
Oakland, California, United States, 94611
Childrens Hospital of Orange County Active, not recruiting
Orange, California, United States, 92868-3874
Lucile Packard Children's Hospital Stanford University Active, not recruiting
Palo Alto, California, United States, 94304
UC Davis Comprehensive Cancer Center Active, not recruiting
Sacramento, California, United States, 95817
Rady Children's Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact: William D. Roberts    858-966-5934      
Principal Investigator: William D. Roberts         
University of California San Francisco Medical Center-Parnassus Active, not recruiting
San Francisco, California, United States, 94143
United States, Connecticut
Connecticut Children's Medical Center Active, not recruiting
Hartford, Connecticut, United States, 06106
United States, Delaware
Alfred I duPont Hospital for Children Active, not recruiting
Wilmington, Delaware, United States, 19803
United States, District of Columbia
Children's National Medical Center Active, not recruiting
Washington, District of Columbia, United States, 20010
Lombardi Comprehensive Cancer Center at Georgetown University Active, not recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Active, not recruiting
Fort Myers, Florida, United States, 33908
Nemours Children's Clinic - Jacksonville Active, not recruiting
Jacksonville, Florida, United States, 32207-8426
University of Miami Miller School of Medicine-Sylvester Cancer Center Active, not recruiting
Miami, Florida, United States, 33136
Nemours Childrens Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Active, not recruiting
Orlando, Florida, United States, 32827
Florida Hospital Active, not recruiting
Orlando, Florida, United States, 32803
UF Cancer Center at Orlando Health Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
All Children's Hospital Active, not recruiting
Saint Petersburg, Florida, United States, 33701
Saint Joseph Children's Hospital of Tampa Active, not recruiting
Tampa, Florida, United States, 33607
United States, Georgia
Children's Healthcare of Atlanta - Egleston Active, not recruiting
Atlanta, Georgia, United States, 30322
Memorial Health University Medical Center Active, not recruiting
Savannah, Georgia, United States, 31403
United States, Hawaii
University of Hawaii Active, not recruiting
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Eugenia Chang    800-845-4624      
Principal Investigator: Eugenia Chang         
United States, Illinois
Lurie Children's Hospital-Chicago Active, not recruiting
Chicago, Illinois, United States, 60614
University of Chicago Active, not recruiting
Chicago, Illinois, United States, 60637
Advocate Children's Hospital-Oak Lawn Active, not recruiting
Oak Lawn, Illinois, United States, 60453
Saint Jude Midwest Affiliate Active, not recruiting
Peoria, Illinois, United States, 61602
United States, Indiana
Riley Hospital for Children Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
Blank Children's Hospital Active, not recruiting
Des Moines, Iowa, United States, 50309
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Martha F. Greenwood    859-257-3379      
Principal Investigator: Martha F. Greenwood         
Kosair Children's Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University Health Sciences Center Active, not recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University-Sidney Kimmel Cancer Center Active, not recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute Withdrawn
Boston, Massachusetts, United States, 02115
United States, Michigan
C S Mott Children's Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Wayne State University-Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
Michigan State University - Breslin Cancer Center Active, not recruiting
Lansing, Michigan, United States, 48910
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Active, not recruiting
Minneapolis, Minnesota, United States, 55404
University of Minnesota Medical Center-Fairview Active, not recruiting
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center Active, not recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
University of Missouri-Columbia Withdrawn
Columbia, Missouri, United States, 65212
The Childrens Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
Saint John's Mercy Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63141
Cardinal Glennon Children's Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nevada
Nevada Cancer Research Foundation CCOP Active, not recruiting
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Dartmouth Hitchcock Medical Center Active, not recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center Active, not recruiting
Hackensack, New Jersey, United States, 07601
Saint Barnabas Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
Newark Beth Israel Medical Center Active, not recruiting
Newark, New Jersey, United States, 07112
Overlook Hospital Recruiting
Summit, New Jersey, United States, 07902
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
United States, New Mexico
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Albany Medical Center Active, not recruiting
Albany, New York, United States, 12208
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467-2490
Contact: Peter D. Cole    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Peter D. Cole         
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Columbia University Medical Center Active, not recruiting
New York, New York, United States, 10032
New York University Langone Medical Center Active, not recruiting
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10065
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
State University of New York Upstate Medical University Active, not recruiting
Syracuse, New York, United States, 13210
Ny Cancer% Active, not recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Presbyterian Hospital Active, not recruiting
Charlotte, North Carolina, United States, 28204
Carolinas Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
Children's Hospital Medical Center of Akron Active, not recruiting
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
Rainbow Babies and Childrens Hospital Active, not recruiting
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital Active, not recruiting
Columbus, Ohio, United States, 43205
The Children's Medical Center of Dayton Active, not recruiting
Dayton, Ohio, United States, 45404
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Legacy Emanuel Children's Hospital Active, not recruiting
Portland, Oregon, United States, 97227
Legacy Emanuel Hospital and Health Center Recruiting
Portland, Oregon, United States, 97227
Contact: Janice F. Olson    503-413-2560      
Principal Investigator: Janice F. Olson         
Oregon Health and Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Geisinger Medical Center Active, not recruiting
Danville, Pennsylvania, United States, 17822-2001
Penn State Hershey Children's Hospital Active, not recruiting
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Rhode Island
Rhode Island Hospital Active, not recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29425
Palmetto Health Richland Active, not recruiting
Columbia, South Carolina, United States, 29203
BI-LO Charities Children's Cancer Center Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Cancer Treatment Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant    864-241-6251      
Principal Investigator: Nichole L. Bryant         
United States, Tennessee
East Tennessee Childrens Hospital Active, not recruiting
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center Active, not recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Dell Children's Medical Center of Central Texas Active, not recruiting
Austin, Texas, United States, 78723
Driscoll Children's Hospital Active, not recruiting
Corpus Christi, Texas, United States, 78411
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky    972-566-5588      
Principal Investigator: Carl Lenarsky         
University of Texas Southwestern Medical Center Active, not recruiting
Dallas, Texas, United States, 75390
Brooke Army Medical Center Active, not recruiting
Fort Sam Houston, Texas, United States, 78234
Cook Children's Medical Center Active, not recruiting
Fort Worth, Texas, United States, 76104
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
Covenant Children's Hospital Active, not recruiting
Lubbock, Texas, United States, 79410
United States, Utah
Primary Children's Hospital Active, not recruiting
Salt Lake City, Utah, United States, 84113
United States, Vermont
University of Vermont Active, not recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Childrens Hospital-King's Daughters Active, not recruiting
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Active, not recruiting
Richmond, Virginia, United States, 23298
United States, Washington
Seattle Children's Hospital Active, not recruiting
Seattle, Washington, United States, 98105
Providence Sacred Heart Medical Center and Children's Hospital Active, not recruiting
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin Hospital and Clinics Active, not recruiting
Madison, Wisconsin, United States, 53792
Midwest Children's Cancer Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Sydney Children's Hospital Active, not recruiting
Randwick, New South Wales, Australia, 2031
The Children's Hospital at Westmead Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Timothy E. Hassall    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Timothy E. Hassall         
Royal Childrens Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Timothy E. Hassall    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Timothy E. Hassall         
Australia, Western Australia
Princess Margaret Hospital for Children Active, not recruiting
Perth, Western Australia, Australia, 6008
Canada, Alberta
Alberta Children's Hospital Active, not recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital Active, not recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba Active, not recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre Active, not recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital Active, not recruiting
Kingston, Ontario, Canada, K7L 5P9
Hospital for Sick Children Active, not recruiting
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine Active, not recruiting
Montreal, Quebec, Canada, H3T 1C5
The Montreal Children's Hospital of the MUHC Active, not recruiting
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier Universitaire de Quebec Active, not recruiting
Ste-Foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Saskatoon Cancer Centre Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Hospital Active, not recruiting
Grafton, Auckland, New Zealand, 1145
Christchurch Hospital Active, not recruiting
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Investigators
Principal Investigator: Adam Levy Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01217437     History of Changes
Other Study ID Numbers: NCI-2011-02605, NCI-2011-02605, CDR0000686608, COG-ACNS0821, ACNS0821, ACNS0821, U10CA098543
Study First Received: October 7, 2010
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Medulloblastoma
Pinealoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies
Antibodies, Monoclonal
Temozolomide
Dacarbazine
Irinotecan
Bevacizumab
Camptothecin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on April 17, 2014