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.
Verified December 2013 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01553149
First received: March 10, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This randomized phase II trial studies low-dose or high-dose lenalidomide to see how well it works in treating younger patients with recurrent, refractory, or progressive juvenile pilocytic astrocytomas or optic nerve pathway gliomas. Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor.


Condition Intervention Phase
Neurofibromatosis Type 1
Recurrent Childhood Pilocytic Astrocytoma
Recurrent Childhood Visual Pathway Glioma
Drug: lenalidomide
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, IND # 70116) 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 5 years ] [ Designated as safety issue: No ]
    The response rate will be calculated as the ratio of the number of patients who demonstrate response (CR or PR) divided by the number of patients evaluable for response.


Secondary Outcome Measures:
  • 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 5 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.

  • Time to death (overall survival [OS]) [ Time Frame: Time from study enrollment to death from any cause ] [ 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.


Estimated Enrollment: 80
Study Start Date: March 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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
  • IMiD-1
  • Revlimid
Experimental: Arm II
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
  • IMiD-1
  • Revlimid

Detailed Description:

PRIMARY OBJECTIVES:

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/m²/dose) or Regimen B high-dose (115 mg/m²/dose) lenalidomide.

SECONDARY OBJECTIVES:

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: This is a multicenter study. 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.

Patients undergo blood sample collection between days 5-21 during course 1 for pharmacokinetic studies.

After completion of study treatment, patients are followed up for up to 5 years.

  Eligibility

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

Inclusion Criteria:

  • 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 been treated with two or fewer anti-cancer regimens, including chemotherapy, biologic agents, immunotherapy, vaccines, monoclonal antibodies, or radiation therapy

    • At least one prior treatment regimen must have included carboplatin
    • Patients who have received prior radiation therapy for this tumor are eligible
  • Patients must have a body surface area (BSA) ≥ 0.4 m² at the time of 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
  • Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (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 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 times upper limit of normal (ULN) for age
  • Serum glutamic 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
  • Not pregnant or breastfeeding

    • 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 (4weeks) 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 not had a menstrual period in the preceding 24 consecutive months or 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 every28 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
  • See Disease Characteristics
  • Patients must have recovered (to common terminology criteria [CTC] 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

    • Must not have received myelosuppressive chemotherapy within 3 weeks of entry onto this study(6 weeks if prior nitrosourea or mitomycin C)
    • 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
    • At least 42 days after the completion of any type of immunotherapy, e.g., tumor vaccines
    • At least 3 half-lives of the antibody after the last dose of a monoclonal antibody
    • Patients must have had their last fraction of craniospinal radiotherapy (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 prior thalidomide are eligible if all acute thalidomide-related toxicity has resolved
      • Patients must not have received lenalidomide previously
  • Must not have received growth factor(s) within 2 weeks of entry onto this study
  • Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to baseline MRI
  • Concurrent cancer therapy, including chemotherapy, radiation therapy, immunotherapy, or biologic therapy, may NOT be administered to patients while on this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553149

  Hide Study Locations
Locations
United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Alyssa T. Reddy    205-934-0309      
Principal Investigator: Alyssa T. Reddy         
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 Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jessica Boklan    602-546-0920      
Principal Investigator: Jessica Boklan         
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202-3591
Contact: David L. Becton    501-364-7373      
Principal Investigator: David L. Becton         
University of Arkansas for Medical Sciences Withdrawn
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group Recruiting
Downey, California, United States, 90242
Contact: Robert M. Cooper    626-564-3455      
Principal Investigator: Robert M. Cooper         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Anna B. Pawlowska    800-826-4673    becomingapatient@coh.org   
Principal Investigator: Anna B. Pawlowska         
Miller Children's Hospital Recruiting
Long Beach, California, United States, 90806
Contact: Amanda M. Termuhlen    562-933-5437      
Principal Investigator: Amanda M. Termuhlen         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Leo Mascarenhas    323-361-4110      
Principal Investigator: Leo Mascarenhas         
Children's Hospital Central California Recruiting
Madera, California, United States, 93636-8762
Contact: Vonda L. Crouse    866-353-5437      
Principal Investigator: Vonda L. Crouse         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868-3874
Contact: Violet Shen    714-997-3000      
Principal Investigator: Violet Shen         
Lucile Packard Children's Hospital Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Neyssa M. Marina    650-498-7061    clinicaltrials@med.stanford.edu   
Principal Investigator: Neyssa M. Marina         
University of California San Francisco Medical Center-Parnassus Recruiting
San Francisco, California, United States, 94143
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 Recruiting
Wilmington, Delaware, United States, 19803
Contact: Christopher N. Frantz    302-651-5755      
Principal Investigator: Christopher N. Frantz         
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
The 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         
Nemours Children's Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207-8426
Contact: Eric S. Sandler    904-697-3529      
Principal Investigator: Eric S. Sandler         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Fouad M. Hajjar    407-303-5623      
Principal Investigator: Fouad M. Hajjar         
Nemours Childrens Clinic - Orlando Withdrawn
Orlando, Florida, United States, 32806
Nemours Children's Hospital Recruiting
Orlando, Florida, United States, 32827
Contact: Ramamoorthy Nagasubramanian    407-650-7150      
Principal Investigator: Ramamoorthy Nagasubramanian         
Nemours Children's Clinic - Pensacola Recruiting
Pensacola, Florida, United States, 32504
Contact: Jeffrey H. Schwartz    904-697-3529      
Principal Investigator: Jeffrey H. Schwartz         
All Children's Hospital Recruiting
Saint Petersburg, Florida, United States, 33701
Contact: Gregory A. Hale    727-767-2423    HamblinF@allkids.org   
Principal Investigator: Gregory A. Hale         
United States, Georgia
Children's Healthcare of Atlanta - Egleston Recruiting
Atlanta, Georgia, United States, 30322
Contact: Glen Lew    404-785-1112      
Principal Investigator: Glen Lew         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31403
Contact: J. M. Johnston    912-350-8568      
Principal Investigator: J. M. Johnston         
United States, Hawaii
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Robert W. Wilkinson    808-983-6090      
Principal Investigator: Robert W. Wilkinson         
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, 60637-1470
Contact: Charles M. Rubin    773-834-7424      
Principal Investigator: Charles M. Rubin         
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, 60614
Contact: David O. Walterhouse    773-880-4562      
Principal Investigator: David O. Walterhouse         
Saint Jude Midwest Affiliate Active, not recruiting
Peoria, Illinois, United States, 61602
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robert J. Fallon    317-274-2552      
Principal Investigator: Robert J. Fallon         
Saint Vincent Hospital and Health Services Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Bassem I. Razzouk    317-338-2194      
Principal Investigator: Bassem I. Razzouk         
United States, Iowa
Raymond 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 Recruiting
Lexington, Kentucky, United States, 40536
Contact: Martha F. Greenwood    859-257-3379      
Principal Investigator: Martha F. Greenwood         
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Salvatore J. Bertolone    866-530-5516      
Principal Investigator: Salvatore J. Bertolone         
United States, Louisiana
Tulane University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Tammuella C. Singleton    504-988-6121      
Principal Investigator: Tammuella C. Singleton         
United States, Maryland
Mark O Hatfield-Warren Grant Magnuson Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Katherine E. Warren    800-411-1222      
Principal Investigator: Katherine E. Warren         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Carlos Rodriguez-Galindo    866-790-4500      
Principal Investigator: Carlos Rodriguez-Galindo         
United States, Michigan
C S Mott Children's Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Wayne State University Recruiting
Detroit, Michigan, United States, 48202
Contact: Zhihong J. Wang    313-576-9363      
Principal Investigator: Zhihong J. Wang         
Michigan State University - Breslin Cancer Center Recruiting
Lansing, Michigan, United States, 48910
Contact: Renuka Gera    517-334-2765      
Principal Investigator: Renuka Gera         
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Bruce C. Bostrom    612-813-5193      
Principal Investigator: Bruce C. Bostrom         
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    601-815-6700      
Principal Investigator: Gail C. Megason         
United States, Missouri
Columbia Regional Recruiting
Columbia, Missouri, United States, 65201
Contact: Thomas W. Loew    573-882-7440      
Principal Investigator: Thomas W. Loew         
The Childrens Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Kathleen A. Neville    816-234-3265      
Principal Investigator: Kathleen A. Neville         
Saint John's Mercy Medical Center 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    info@siteman.wustl.edu   
Principal Investigator: Joshua B. Rubin         
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: Jonathan Bernstein    702-384-0013      
Principal Investigator: Jonathan Bernstein         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Sara Chaffee    800-639-6918    cancer.research.nurse@dartmouth.edu   
Principal Investigator: Sara Chaffee         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Burton E. Appel    201-996-2879      
Principal Investigator: Burton E. Appel         
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
Contact: Steven L. Halpern    973-971-5900      
Principal Investigator: Steven L. Halpern         
UMDNJ - Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Richard A. Drachtman    732-235-8675      
Principal Investigator: Richard A. Drachtman         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Koh B. Boayue    505-272-6972      
Principal Investigator: Koh B. Boayue         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467-2490
Contact: Rosanna J. Ricafort    718-904-2730    aecc@aecom.yu.edu   
Principal Investigator: Rosanna J. Ricafort         
Roswell Park Cancer Institute Active, not recruiting
Buffalo, New York, United States, 14263
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Alice Lee    212-305-8615      
Principal Investigator: Alice Lee         
New York University Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jeffrey C. Allen    212-263-4434    prmc.coordinator@nyumc.org   
Principal Investigator: Jeffrey C. Allen         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Karol H. Kerr    315-464-5476      
Principal Investigator: Karol H. Kerr         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Joel A. Kaplan    704-355-2884      
Principal Investigator: Joel A. Kaplan         
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 Recruiting
Cincinnati, Ohio, United States, 45229
Contact: John P. Perentesis    513-636-2799      
Principal Investigator: John P. Perentesis         
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 Recruiting
Columbus, Ohio, United States, 43205
Contact: Mark A. Ranalli    614-722-2708      
Principal Investigator: Mark A. Ranalli         
The Children's Medical Center of Dayton Recruiting
Dayton, Ohio, United States, 45404
Contact: Emmett H. Broxson    800-228-4055      
Principal Investigator: Emmett H. Broxson         
Mercy Children's Hospital Recruiting
Toledo, Ohio, United States, 43608
Contact: Rama Jasty    419-251-8210      
Principal Investigator: Rama Jasty         
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Rene Y. McNall-Knapp    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Rene Y. McNall-Knapp         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Katherine E. Warren    301-435-4683    warrenk@mail.nih.gov   
Principal Investigator: Katherine E. Warren         
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Lisa M. McGregor    717-531-6012      
Principal Investigator: Lisa M. McGregor         
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Regina I. Jakacki    412-692-5573      
Principal Investigator: Regina I. Jakacki         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jacqueline M. Kraveka    843-792-9321      
Principal Investigator: Jacqueline M. Kraveka         
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 Recruiting
Knoxville, Tennessee, United States, 37916
Contact: Ray C. Pais    865-541-8266      
Principal Investigator: Ray C. Pais         
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Wayne L. Furman    901-595-4644      
Principal Investigator: Wayne L. Furman         
Vanderbilt-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: Sharon K. Lockhart    512-324-8022      
Principal Investigator: Sharon K. Lockhart         
Driscoll Children's Hospital Recruiting
Corpus Christi, Texas, United States, 78411
Contact: M. C. Johnson    361-694-5311      
Principal Investigator: M. C. Johnson         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Naomi J. Winick    214-648-7097      
Principal Investigator: Naomi J. Winick         
Medical City Dallas Hospital Recruiting
Dallas, Texas, United States, 75230
Contact: Carl Lenarsky    972-566-5588      
Principal Investigator: Carl Lenarsky         
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Mary Meaghan P. Granger    682-885-2103      
Principal Investigator: Mary Meaghan P. Granger         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Lisa R. Bomgaars    713-798-1354    burton@bcm.edu   
Principal Investigator: Lisa R. Bomgaars         
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: Sarah Leary    866-987-2000      
Principal Investigator: Sarah Leary         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Judy L. Felgenhauer    800-228-6618    HopeBeginsHere@providence.org   
Principal Investigator: Judy L. Felgenhauer         
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 Recruiting
Perth, Western Australia, Australia, 6008
Contact: Catherine H. Cole    (08) 9340 8330    admin@childcancerresearch.com.au   
Principal Investigator: Catherine H. Cole         
Canada, British Columbia
British Columbia Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Caron Strahlendorf    604-875-2345ext6477      
Principal Investigator: Caron Strahlendorf         
Canada, Nova Scotia
IWK Health Centre Recruiting
Halifax, Nova Scotia, Canada, B3J 3G9
Contact: Margaret C. Yhap    902-470-8394      
Principal Investigator: Margaret C. Yhap         
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Carol Portwine    905-521-2100ext74595      
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
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Yvan Samson    514-345-4931      
Principal Investigator: Yvan Samson         
The Montreal Children's Hospital of the MUHC Recruiting
Montreal, Quebec, Canada, H3H 1P3
Contact: Sharon B. Abish    514-412-4445    info@thechildren.com   
Principal Investigator: Sharon B. Abish         
New Zealand
Starship Children's Hospital Recruiting
Grafton, Auckland, New Zealand, 1145
Contact: Lochie R. Teague    0800 728 436      
Principal Investigator: Lochie R. Teague         
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine Warren Children's Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01553149     History of Changes
Other Study ID Numbers: NCI-2012-00703, NCI-2012-00703, CDR0000728296, COG-ACNS1022, ACNS1022, ACNS1022, U10CA098543
Study First Received: March 10, 2012
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Astrocytoma
Glioma
Neurofibromatoses
Neurofibromatosis 1
Osteitis Fibrosa Cystica
Optic Nerve Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neurofibroma
Nerve Sheath Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Optic Nerve Neoplasms
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 17, 2014