Trial record 1 of 1 for:    NCT01553149
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Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI) Identifier:
First received: March 10, 2012
Last updated: May 26, 2016
Last verified: December 2015
This randomized phase II trial studies how well low-dose lenalidomide works compared with high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment (refractory), or are growing, spreading, or getting worse (progressive). Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether low-dose lenalidomide is more or less effective than high-dose lenalidomide in treating patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas.

Condition Intervention Phase
Neurofibromatosis Type 1
Recurrent Childhood Pilocytic Astrocytoma
Recurrent Childhood Visual Pathway Glioma
Drug: Lenalidomide
Other: Pharmacological Study
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: A Phase II Randomized Trial of Lenalidomide (NSC # 703813) in Pediatric Patients With Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Objective response - best response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The response rate will be calculated as the ratio of the number of patients who demonstrate response (complete response [CR] or partial response [PR]) divided by the number of patients evaluable for response.

Secondary Outcome Measures:
  • Incidence of toxic events defined as one in which a patient has two dose reductions and then experiences another significant toxicity using Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Estimates will be obtained using life-table methods, with an event defined as the first occurrence of a primary toxicity. The rates of individual toxicities in each course of treatment, the number of patients who require a dose reduction and number of patients who come off protocol therapy due to toxicity will be summarized using standard descriptive statistical methods.

  • MRI sequence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Response categories (CR, PR, stable disease, and progression) will be determined from the following three standard MR sequences, T2-weighted, FLAIR, T1-weighted post-contrast. Percent agreement between the sequences will be estimated as the number of follow-up scans in which the corresponding sequence agreed divided by the total number of follow-up scans. Standard error will be estimated by use of the bootstrap method to account for the correlated dependent response data, and these values will be used to estimate the 95% confidence intervals.

  • Pharmacokinetic parameters of lenalidomide [ Time Frame: Between days 5-21 of course 1 and each dose reduction ] [ Designated as safety issue: No ]
    Correlation of lenalidomide concentration obtained from the steady-state sample and the number of cycles received prior to the occurrence of disease progression will be performed using Pearson's correlation coefficient. Cox regression analysis will be used to assess the association between outcome and steady state levels at a particular cycle.

  • Time to death (overall survival [OS]) [ Time Frame: Time from study enrollment to death from any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
    Standard survival methods will be used for analysis of OS. Analyses include log rank tests and the product-limit (Kaplan-Meier) estimate for estimation of OS probability.

  • Time to treatment failure (EFS) [ Time Frame: Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 3 years ] [ Designated as safety issue: No ]
    Standard survival methods will be used for analysis of EFS. Analyses include log rank tests and the product-limit (Kaplan-Meier) estimate for estimation of EFS probability.

Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (low-dose lenalidomide)
Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
Other: Pharmacological Study
Correlative studies
Experimental: Arm II (high-dose lenalidomide)
Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
Other: Pharmacological Study
Correlative studies

Detailed Description:


I. To determine the objective response rate in children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with Regimen A low-dose (20 mg/m^2/dose) or Regimen B high-dose (115 mg/m^2/dose) lenalidomide.


I. To estimate the event-free survival (EFS) (based on standard two-dimensional tumor measurements, determined by each institution) of children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with lenalidomide.

II. To compare response categories and EFS across the 3 magnetic resonance (MR) sequences (T2-weighted, fluid attenuated inversion recovery [FLAIR], T1-weighted post-contrast).

III. To correlate steady-state pharmacokinetics of lenalidomide (1 sample obtained between days 5-21) with objective response and EFS.

IV. To evaluate toxicities of long-term lenalidomide use.

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

ARM I (Regimen A): Patients receive low-dose lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

ARM II (Regimen B): Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually for approximately 3 years.


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

Inclusion Criteria:

  • Patients must have a body surface area (BSA) >= 0.4 m^2 at the time of study enrollment
  • Patients must have a pilocytic astrocytoma or optic pathway glioma that has relapsed, progressed, or become refractory to conventional therapy; patients with neurofibromatosis (NF-1) are eligible
  • Patients must have histologic verification of malignancy; histologic confirmation for patients with optic pathway gliomas will not be required
  • Patients must have measurable residual disease, defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI); for a lesion to be considered measurable, it must be at least twice the slice thickness on MRI (i.e. visible on more than one slice)
  • To document the degree of residual tumor, the following must be obtained:

    • All patients must have a brain MRI with and without contrast (gadolinium) within 1 week prior to study enrollment; for patients on steroids, baseline MRI scans must be performed after at least 1 week at a stable or decreasing dose of steroids
    • All patients with a history of spinal or leptomeningeal disease, and those patients with symptoms suspicious of spinal disease, must have a spine MRI with and without contrast (gadolinium) performed within 2 weeks prior to study enrollment
  • Patients must have a Lansky or Karnofsky performance status score of >= 60%; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Patients must have been treated with at least one prior treatment regimen that included carboplatin; patients who have received prior radiation therapy for this tumor are eligible
  • Patients must have recovered (to Common Toxicity Criteria [CTC] version [v.]4.0 =< grade 1 unless indicated below) from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, with the exception of alopecia, weight changes and grade I or II lymphopenia

    • Myelosuppressive chemotherapy: must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea or mitomycin-C)
    • Biologic (anti-neoplastic agent): at least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur
    • Immunotherapy: at least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines
    • Monoclonal antibodies: at least 3 half-lives of the antibody after the last dose of a monoclonal antibody
    • Radiation therapy (RT): patients must have had their last fraction of craniospinal RT >= 6 months prior to study entry and their last fraction of focal RT >= 4 weeks prior to study entry; if the lesion used for on-study criteria is in the radiation field, there must be evidence of tumor progression after radiation therapy was completed
    • Study specific limitations on prior therapy:

      • Patients who have received thalidomide are eligible if all acute thalidomide-related toxicity has resolved
      • Patients must not have received lenalidomide previously
  • Growth factor(s): must not have received within 2 weeks of entry onto this study
  • Steroids: patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to baseline MRI
  • Peripheral absolute neutrophil count (ANC) >= 1,000/uL
  • Platelet count >= 100,000/uL (transfusion independent)
  • Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)
  • Creatinine clearance or radioisotope glomerular filtration rate(GFR) >= 70 mL/min/m^2 OR a serum creatinine based on age/gender as follows:

    • 0.4 mg/dL (1 month to < 6 months of age)
    • 0.5 mg/dL (6 months to < 1 year of age)
    • 0.6 mg/dL (1 to < 2 years of age)
    • 0.8 mg/dL (2 to < 6 years of age)
    • 1.0 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)
  • Total bilirubin =< 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 is 45 U/L
  • Serum albumin >= 2 g/dL
  • No evidence of dyspnea at rest and a pulse oximetry > 94% if there is clinical indication for determination
  • Patients must be able to swallow intact capsules
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Female patients who are pregnant are not eligible
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants while receiving protocol therapy and for 28 days after the last dose of lenalidomide
  • Female patients of childbearing potential are not eligible unless they commit to complete abstinence or have been on 2 methods of birth control, including 1 highly effective method and 1 additional method at the same time (unless committing to complete abstinence of heterosexual intercourse) at least 28 days (4 weeks) prior to study enrollment; sexually active females must also agree to remain on 2 methods of birth control, during treatment (including during dose interruptions), and continuing for at least 28 days after the completion of protocol therapy; examples of methods of contraception are as follows:

    • Highly effective methods (must use at least 1):

      • Intrauterine device (IUD)
      • Hormonal (prescription birth control pills, injections, implants)
      • Tubal ligation
      • Partner's vasectomy
    • Additional effective methods:

      • Male condom
      • Diaphragm
      • Cervical cap The two methods of birth control requirement applies to all sexually active females unless they have undergone a hysterectomy or bilateral oophorectomy
  • Female patients of childbearing potential (including those who commit to complete abstinence) are not eligible unless they agree to ongoing pregnancy testing and counseling every 28 days about pregnancy precautions and risks of fetal exposure
  • Male patients of child fathering potential are not eligible unless they have agreed to use latex condoms during intercourse with a woman of childbearing potential while receiving treatment and for 28 days thereafter
  • Patients with a history of thromboembolism unrelated to a central line, or patients with a known predisposition syndrome for thromboembolism are not eligible
  • Patients who have an uncontrolled or untreated infection are not eligible
  • Patients with known overt cardiac disease, including but not limited to a history of myocardial infarction, severe or unstable angina, clinically significant peripheral vascular disease, grade 2 or greater heart failure, or serious and inadequately controlled cardiac arrhythmia are not eligible
  • Patients with a significant systemic illness that is not well-controlled in the opinion of the treating physician are not eligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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 identifier: NCT01553149

  Hide Study Locations
United States, Alabama
Children's Hospital of Alabama Suspended
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham Cancer Center Suspended
Birmingham, Alabama, United States, 35233
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
City of Hope Comprehensive Cancer Center Active, not recruiting
Duarte, California, United States, 91010
Loma Linda University Medical Center Recruiting
Loma Linda, California, United States, 92354
Contact: Albert Kheradpour    909-558-3375      
Principal Investigator: Albert Kheradpour         
Miller Children's and Women's Hospital Long Beach Recruiting
Long Beach, California, United States, 90806
Contact: Pamela H. Kempert    562-933-5600   
Principal Investigator: Pamela H. Kempert         
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 Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Kaiser Permanente-Oakland Recruiting
Oakland, California, United States, 94611
Contact: Steven K. Bergstrom    626-564-3455      
Principal Investigator: Steven K. Bergstrom         
Children's Hospital of Orange County Active, not recruiting
Orange, California, United States, 92868
Lucile Packard Children's Hospital Stanford University Active, not recruiting
Palo Alto, California, United States, 94304
Sutter General Hospital Recruiting
Sacramento, California, United States, 95816
Contact: Yung S. Yim    415-209-2686   
Principal Investigator: Yung S. Yim         
University of California Davis Comprehensive Cancer Center Active, not recruiting
Sacramento, California, United States, 95817
UCSF Medical Center-Parnassus Suspended
San Francisco, California, United States, 94143
UCSF Medical Center-Mission Bay Recruiting
San Francisco, California, United States, 94158
Contact: Anuradha Banerjee    877-827-3222   
Principal Investigator: Anuradha Banerjee         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Margaret E. Macy    720-777-6672      
Principal Investigator: Margaret E. Macy         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Michael S. Isakoff    860-545-9981      
Principal Investigator: Michael S. Isakoff         
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 Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jeffrey S. Dome    202-884-2549      
Principal Investigator: Jeffrey S. Dome         
United States, Florida
Lee Memorial Health System Withdrawn
Fort Myers, Florida, United States, 33901
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
Contact: Emad K. Salman    239-343-5333      
Principal Investigator: Emad K. Salman         
University of Florida Withdrawn
Gainesville, Florida, United States, 32610
Nemours Children's Clinic-Jacksonville Active, not recruiting
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Arnold Palmer Hospital for Children Recruiting
Orlando, Florida, United States, 32806
Contact: Vincent F. Giusti    321-841-7743   
Principal Investigator: Vincent F. Giusti         
Florida Hospital Orlando Active, not recruiting
Orlando, Florida, United States, 32803
Nemours Children's Hospital Active, not recruiting
Orlando, Florida, United States, 32827
Nemours Children's Clinic - Pensacola Active, not recruiting
Pensacola, Florida, United States, 32504
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423   
Principal Investigator: Gregory A. Hale         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Suspended
Atlanta, Georgia, United States, 30322
Memorial University Medical Center Active, not recruiting
Savannah, Georgia, United States, 31404
United States, Hawaii
University of Hawaii Cancer Center Withdrawn
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
University of Chicago Comprehensive Cancer Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Susan L. Cohn    773-834-1329   
Principal Investigator: Susan L. Cohn         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary L. Schmidt    312-355-3046      
Principal Investigator: Mary L. Schmidt         
Lurie Children's Hospital-Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Stewart Goldman    773-880-4562      
Principal Investigator: Stewart Goldman         
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Eugene Suh    708-226-4357      
Principal Investigator: Eugene Suh         
Advocate Children's Hospital-Oak Lawn Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Rebecca E. McFall    847-723-7570   
Principal Investigator: Rebecca E. McFall         
Saint Jude Midwest Affiliate Recruiting
Peoria, Illinois, United States, 61637
Contact: Karen S. Fernandez    309-655-3258      
Principal Investigator: Karen S. Fernandez         
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-948-0616   
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Care Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194   
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Blank Children's Hospital Recruiting
Des Moines, Iowa, United States, 50309
Contact: Wendy L. Woods-Swafford    515-241-6729      
Principal Investigator: Wendy L. Woods-Swafford         
United States, Kentucky
University of Kentucky/Markey Cancer Center Active, not recruiting
Lexington, Kentucky, United States, 40536
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Kenneth G. Lucas    502-852-8453   
Principal Investigator: Kenneth G. Lucas         
United States, Louisiana
Ochsner Medical Center Jefferson Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Craig Lotterman    888-562-4763      
Principal Investigator: Craig Lotterman         
Children's Hospital New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lolie C. Yu    504-894-5377      
Principal Investigator: Lolie C. Yu         
Tulane University Health Sciences Center Withdrawn
New Orleans, Louisiana, United States, 70112
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Katherine E. Warren    301-480-2308   
Principal Investigator: Katherine E. Warren         
United States, Massachusetts
Dana-Farber/Harvard Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
C S Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Patricia L. Robertson    800-865-1125      
Principal Investigator: Patricia L. Robertson         
Wayne State University/Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Zhihong J. Wang    313-576-9363      
Principal Investigator: Zhihong J. Wang         
Michigan State University Clinical Center Active, not recruiting
East Lansing, Michigan, United States, 48824-7016
Helen DeVos Children's Hospital at Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: David S. Dickens    616-267-1925   
Principal Investigator: David S. Dickens         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Michael K. Richards    612-813-5193      
Principal Investigator: Michael K. Richards         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Amulya A. Nageswara Rao    507-538-7623      
Principal Investigator: Amulya A. Nageswara Rao         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Gail C. Megason    601-984-5279   
Principal Investigator: Gail C. Megason         
United States, Missouri
Columbia Regional Active, not recruiting
Columbia, Missouri, United States, 65201
The Childrens Mercy Hospital Suspended
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Medical Center Recruiting
Saint Louis, Missouri, United States, 63104
Contact: William S. Ferguson    314-268-4000      
Principal Investigator: William S. Ferguson         
Mercy Hospital Saint Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman    913-948-5588      
Principal Investigator: Bethany G. Sleckman         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joshua B. Rubin    800-600-3606   
Principal Investigator: Joshua B. Rubin         
United States, Nebraska
Children's Hospital and Medical Center of Omaha Recruiting
Omaha, Nebraska, United States, 68114
Contact: Minnie Abromowitch    402-955-3972   
Principal Investigator: Minnie Abromowitch         
United States, Nevada
Nevada Cancer Research Foundation CCOP Active, not recruiting
Las Vegas, Nevada, United States, 89106
Children's Specialty Center of Nevada II Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Jonathan Bernstein    702-384-0013   
Principal Investigator: Jonathan Bernstein         
Summerlin Hospital Medical Center Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Jonathan Bernstein    702-384-0013   
Principal Investigator: Jonathan Bernstein         
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 Withdrawn
Hackensack, New Jersey, United States, 07601
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07960
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Active, not recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
University of New Mexico Cancer Center Active, not recruiting
Albuquerque, New Mexico, United States, 87102
United States, New York
Montefiore Medical Center - Moses Campus Active, not recruiting
Bronx, New York, United States, 10467-2490
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Laura and Isaac Perlmutter Cancer Center at NYU Langone Recruiting
New York, New York, United States, 10016
Contact: Jeffrey C. Allen    212-263-4434   
Principal Investigator: Jeffrey C. Allen         
Columbia University/Herbert Irving Cancer Center Active, not recruiting
New York, New York, United States, 10032
State University of New York Upstate Medical University Active, not recruiting
Syracuse, New York, United States, 13210
New York Medical College Active, not recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Stuart H. Gold    919-966-7629   
Principal Investigator: Stuart H. Gold         
Carolinas Medical Center/Levine Cancer Institute Active, not recruiting
Charlotte, North Carolina, United States, 28203
East Carolina University Active, not recruiting
Greenville, North Carolina, United States, 27858
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Steven J. Kuerbitz    330-543-3193      
Principal Investigator: Steven J. Kuerbitz         
Cincinnati Children's Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Childrens Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Yousif (Joe) H. Matloub    216-844-5437      
Principal Investigator: Yousif (Joe) H. Matloub         
Nationwide Children's Hospital Active, not recruiting
Columbus, Ohio, United States, 43205
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Ayman A. El-Sheikh    937-641-3296   
Principal Investigator: Ayman A. El-Sheikh         
Mercy Children's Hospital Terminated
Toledo, Ohio, United States, 43608
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-8777   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kellie J. Nazemi    503-494-1080   
Principal Investigator: Kellie J. Nazemi         
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-4787   
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael J. Fisher    215-590-4183   
Principal Investigator: Michael J. Fisher         
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Jean M. Tersak    412-692-7693   
Principal Investigator: Jean M. Tersak         
United States, South Carolina
Medical University of South Carolina Suspended
Charleston, South Carolina, United States, 29425
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Ronnie W. Neuberg    803-434-3680      
Principal Investigator: Ronnie W. Neuberg         
BI-LO Charities Children's Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Nichole L. Bryant    864-241-6251      
Principal Investigator: Nichole L. Bryant         
United States, South Dakota
Sanford USD Medical Center - Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57117-5134
Contact: Kayelyn J. Wagner    605-328-1367      
Principal Investigator: Kayelyn J. Wagner         
United States, Tennessee
East Tennessee Childrens Hospital Active, not recruiting
Knoxville, Tennessee, United States, 37916
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    901-521-9005   
Principal Investigator: Wayne L. Furman         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Adam Esbenshade    800-811-8480      
Principal Investigator: Adam Esbenshade         
United States, Texas
Dell Children's Medical Center of Central Texas Recruiting
Austin, Texas, United States, 78723
Contact: Amy C. Fowler    214-648-7097      
Principal Investigator: Amy C. Fowler         
Driscoll Children's Hospital Active, not recruiting
Corpus Christi, Texas, United States, 78411
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Daniel C. Bowers    214-648-7097      
Principal Investigator: Daniel C. Bowers         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Stanton C. Goldman    972-566-5588      
Principal Investigator: Stanton C. Goldman         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Jeffrey C. Murray    682-885-1713   
Principal Investigator: Jeffrey C. Murray         
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jack M. Su    713-798-1354   
Principal Investigator: Jack M. Su         
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Phillip E. Barnette    801-662-4707   
Principal Investigator: Phillip E. Barnette         
United States, Virginia
Childrens Hospital-King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Eric J. Lowe    757-668-7243      
Principal Investigator: Eric J. Lowe         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas S. Hawkins    866-987-2000      
Principal Investigator: Douglas S. Hawkins         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618   
Principal Investigator: Judy L. Felgenhauer         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Kenneth B. De Santes    715-422-7718      
Principal Investigator: Kenneth B. De Santes         
Midwest Children's Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Jeffrey A. Knipstein    414-955-6543   
Principal Investigator: Jeffrey A. Knipstein         
Australia, Queensland
Royal Brisbane and Women's Hospital Suspended
Herston, Queensland, Australia, 4029
Royal Children's Hospital-Brisbane Suspended
Herston, Queensland, Australia, 4029
Lady Cilento Children's Hospital Recruiting
South Brisbane, Queensland, Australia, 4101
Contact: Helen Irving    000-000-0000   
Principal Investigator: Helen Irving         
Australia, Victoria
Royal Children's Hospital Recruiting
Parkville, Victoria, Australia, 3052
Contact: Francoise M. Mechinaud    61-3-9345-4481   
Principal Investigator: Francoise M. Mechinaud         
Australia, Western Australia
Princess Margaret Hospital for Children Recruiting
Perth, Western Australia, Australia, 6008
Contact: Catherine H. Cole    (08) 9340 8222   
Principal Investigator: Catherine H. Cole         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf    604-875-2345 ext 6477      
Principal Investigator: Caron Strahlendorf         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Conrad V. Fernandez    902-470-8394      
Principal Investigator: Conrad V. Fernandez         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100 ext 74595      
Principal Investigator: Carol Portwine         
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: Mariana P. Silva    613-544-2630      
Principal Investigator: Mariana P. Silva         
Canada, Quebec
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4445   
Principal Investigator: Sharon B. Abish         
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand, 1145
Contact: Mark A. Winstanley    64-9-3074923   
Principal Investigator: Mark A. Winstanley         
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Contact: Siobhan F. Cross    03 364 0640      
Principal Investigator: Siobhan F. Cross         
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Katherine Warren Children's Oncology Group
  More Information

Responsible Party: National Cancer Institute (NCI) Identifier: NCT01553149     History of Changes
Other Study ID Numbers: NCI-2012-00703  NCI-2012-00703  CDR0000728296  COG-ACNS1022  ACNS1022  ACNS1022  U10CA180886  U10CA098543 
Study First Received: March 10, 2012
Last Updated: May 26, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurofibromatosis 1
Optic Nerve Glioma
Cranial Nerve Diseases
Cranial Nerve Neoplasms
Eye Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplastic Syndromes, Hereditary
Nerve Sheath Neoplasms
Nervous System Diseases
Nervous System Neoplasms
Neurocutaneous Syndromes
Neurodegenerative Diseases
Neuroectodermal Tumors
Neuromuscular Diseases
Optic Nerve Diseases
Optic Nerve Neoplasms
Peripheral Nervous System Diseases
Peripheral Nervous System Neoplasms processed this record on May 26, 2016