Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01553149 : Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma
PhasePhase 2
AgesMin: N/A Max: 21 Years
Eligibility
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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01553149      |      Link to official Clinicaltrials.gov listing
Locations
South Brisbane, Queensland
Australia

Facility: Lady Cilento Children's Hospital
Investigator: Helen Irving
Contact: Helen Irving Phone: 000-000-0000
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Parkville, Victoria
Australia

Facility: Royal Children's Hospital
Investigator: Francoise M. Mechinaud
Contact: Francoise M. Mechinaud Phone: 61-3-9345-4481
Click HERE to send email to this center

Perth, Western Australia
Australia

Facility: Princess Margaret Hospital for Children
Investigator: Catherine H. Cole
Contact: Catherine H. Cole Phone: 08-9340-8222
Click HERE to send email to this center

Vancouver, British Columbia
Canada

Facility: British Columbia Children's Hospital
Investigator: David B. Dix
Contact: David B. Dix Phone: 604-875-2345
Click HERE to send email to this center

Halifax, Nova Scotia
Canada

Facility: IWK Health Centre
Investigator: Conrad V. Fernandez
Contact: Conrad V. Fernandez Phone: 902-470-8394
Email not avaialable

Hamilton, Ontario
Canada

Facility: McMaster Children's Hospital at Hamilton Health Sciences
Investigator: Carol Portwine
Contact: Carol Portwine Phone: 905-521-2100
Email not avaialable

Kingston, Ontario
Canada

Facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital
Investigator: Mariana P. Silva
Contact: Mariana P. Silva Phone: 613-544-2630
Email not avaialable

Montreal, Quebec
Canada

Facility: The Montreal Children's Hospital of the MUHC
Investigator: Sharon B. Abish
Contact: Sharon B. Abish Phone: 514-412-4445
Click HERE to send email to this center

Montreal, Quebec
Canada

Facility: Centre Hospitalier Universitaire Sainte-Justine
Investigator: Yvan Samson
Contact: Yvan Samson Phone: 514-345-4931
Email not avaialable

Little Rock, Arkansas
Facility: Arkansas Children's Hospital
Investigator: David L. Becton
Contact: David L. Becton Phone: 501-364-7373
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Loma Linda, California
Facility: Loma Linda University Medical Center
Investigator: Albert Kheradpour
Contact: Albert Kheradpour Phone: 909-558-3375
Email not avaialable

Long Beach, California
Facility: Miller Children's and Women's Hospital Long Beach
Investigator: Pamela H. Kempert
Contact: Pamela H. Kempert Phone: 562-933-5600
Click HERE to send email to this center

Los Angeles, California
Facility: Children's Hospital Los Angeles
Investigator: Leo Mascarenhas
Contact: Leo Mascarenhas Phone: 323-361-4110
Email not avaialable

Madera, California
Facility: Children's Hospital Central California
Investigator: Vonda L. Crouse
Contact: Vonda L. Crouse Phone: 866-353-5437
Email not avaialable

Oakland, California
Facility: Kaiser Permanente-Oakland
Investigator: Steven K. Bergstrom
Contact: Steven K. Bergstrom Phone: 626-564-3455
Email not avaialable

Sacramento, California
Facility: Sutter General Hospital
Investigator: Yung S. Yim
Contact: Yung S. Yim Phone: 415-209-2686
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San Francisco, California
Facility: UCSF Medical Center-Mission Bay
Investigator: Anuradha Banerjee
Contact: Anuradha Banerjee Phone: 877-827-3222
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Aurora, Colorado
Facility: Children's Hospital Colorado
Investigator: Margaret E. Macy
Contact: Margaret E. Macy Phone: 720-777-6672
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Hartford, Connecticut
Facility: Connecticut Children's Medical Center
Investigator: Michael S. Isakoff
Contact: Michael S. Isakoff Phone: 860-545-9981
Email not avaialable

Washington, District of Columbia
Facility: Children's National Medical Center
Investigator: Jeffrey S. Dome
Contact: Jeffrey S. Dome Phone: 202-884-2549
Email not avaialable

Fort Myers, Florida
Facility: Golisano Children's Hospital of Southwest Florida
Investigator: Emad K. Salman
Contact: Emad K. Salman Phone: 239-343-5333
Email not avaialable

Orlando, Florida
Facility: Florida Hospital Orlando
Investigator: Fouad M. Hajjar
Contact: Fouad M. Hajjar Phone: 407-303-5623
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Orlando, Florida
Facility: Arnold Palmer Hospital for Children
Investigator: Vincent F. Giusti
Contact: Vincent F. Giusti Phone: 321-841-7743
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Saint Petersburg, Florida
Facility: All Children's Hospital
Investigator: Gregory A. Hale
Contact: Gregory A. Hale Phone: 727-767-2423
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Boise, Idaho
Facility: Saint Luke's Mountain States Tumor Institute
Investigator: Eugenia Chang
Contact: Eugenia Chang Phone: 800-845-4624
Email not avaialable

Chicago, Illinois
Facility: Lurie Children's Hospital-Chicago
Investigator: Stewart Goldman
Contact: Stewart Goldman Phone: 773-880-4562
Email not avaialable

Chicago, Illinois
Facility: University of Illinois
Investigator: Mary L. Schmidt
Contact: Mary L. Schmidt Phone: 312-355-3046
Email not avaialable

Chicago, Illinois
Facility: University of Chicago Comprehensive Cancer Center
Investigator: Susan L. Cohn
Contact: Susan L. Cohn Phone: 773-834-1329
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Maywood, Illinois
Facility: Loyola University Medical Center
Investigator: Eugene Suh
Contact: Eugene Suh Phone: 708-226-4357
Email not avaialable

Oak Lawn, Illinois
Facility: Advocate Children's Hospital-Oak Lawn
Investigator: Rebecca E. McFall
Contact: Rebecca E. McFall Phone: 847-723-7570
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Peoria, Illinois
Facility: Saint Jude Midwest Affiliate
Investigator: Karen S. Fernandez
Contact: Karen S. Fernandez Phone: 309-655-3258
Email not avaialable

Indianapolis, Indiana
Facility: Riley Hospital for Children
Investigator: Robert J. Fallon
Contact: Robert J. Fallon Phone: 317-948-0616
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Indianapolis, Indiana
Facility: Saint Vincent Hospital and Health Care Center
Investigator: Bassem I. Razzouk
Contact: Bassem I. Razzouk Phone: 317-338-2194
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Des Moines, Iowa
Facility: Blank Children's Hospital
Investigator: Wendy L. Woods-Swafford
Contact: Wendy L. Woods-Swafford Phone: 515-241-6729
Email not avaialable

Louisville, Kentucky
Facility: Kosair Children's Hospital
Investigator: Kenneth G. Lucas
Contact: Kenneth G. Lucas Phone: 502-852-8453
Click HERE to send email to this center

New Orleans, Louisiana
Facility: Children's Hospital New Orleans
Investigator: Lolie C. Yu
Contact: Lolie C. Yu Phone: 504-894-5377
Email not avaialable

New Orleans, Louisiana
Facility: Ochsner Medical Center Jefferson
Investigator: Craig Lotterman
Contact: Craig Lotterman Phone: 888-562-4763
Email not avaialable

Bethesda, Maryland
Facility: National Institutes of Health Clinical Center
Investigator: Katherine E. Warren
Contact: Katherine E. Warren Phone: 301-480-2308
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Ann Arbor, Michigan
Facility: C S Mott Children's Hospital
Investigator: Patricia L. Robertson
Contact: Patricia L. Robertson Phone: 800-865-1125
Email not avaialable

Detroit, Michigan
Facility: Wayne State University/Karmanos Cancer Institute
Investigator: Zhihong J. Wang
Contact: Zhihong J. Wang Phone: 313-576-9363
Email not avaialable

Grand Rapids, Michigan
Facility: Helen DeVos Children's Hospital at Spectrum Health
Investigator: David S. Dickens
Contact: David S. Dickens Phone: 616-267-1925
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Minneapolis, Minnesota
Facility: Children's Hospitals and Clinics of Minnesota - Minneapolis
Investigator: Michael K. Richards
Contact: Michael K. Richards Phone: 612-813-5193
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic
Investigator: Amulya A. Nageswara Rao
Contact: Amulya A. Nageswara Rao Phone: 507-538-7623
Email not avaialable

Jackson, Mississippi
Facility: University of Mississippi Medical Center
Investigator: Gail C. Megason
Contact: Gail C. Megason Phone: 601-984-5279
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Saint Louis, Missouri
Facility: Cardinal Glennon Children's Medical Center
Investigator: William S. Ferguson
Contact: William S. Ferguson Phone: 314-268-4000
Email not avaialable

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Joshua B. Rubin
Contact: Joshua B. Rubin Phone: 800-600-3606
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Saint Louis, Missouri
Facility: Mercy Hospital Saint Louis
Investigator: Bethany G. Sleckman
Contact: Bethany G. Sleckman Phone: 913-948-5588
Email not avaialable

Omaha, Nebraska
Facility: Children's Hospital and Medical Center of Omaha
Investigator: Minnie Abromowitch
Contact: Minnie Abromowitch Phone: 402-955-3972
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Las Vegas, Nevada
Facility: Children's Specialty Center of Nevada II
Investigator: Jonathan Bernstein
Contact: Jonathan Bernstein Phone: 702-384-0013
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Las Vegas, Nevada
Facility: Summerlin Hospital Medical Center
Investigator: Jonathan Bernstein
Contact: Jonathan Bernstein Phone: 702-384-0013
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New York, New York
Facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
Investigator: Jeffrey C. Allen
Contact: Jeffrey C. Allen Phone: 212-263-4434
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Chapel Hill, North Carolina
Facility: UNC Lineberger Comprehensive Cancer Center
Investigator: Stuart H. Gold
Contact: Stuart H. Gold Phone: 919-966-7629
Click HERE to send email to this center

Akron, Ohio
Facility: Children's Hospital Medical Center of Akron
Investigator: Steven J. Kuerbitz
Contact: Steven J. Kuerbitz Phone: 330-543-3193
Email not avaialable

Cleveland, Ohio
Facility: Rainbow Babies and Childrens Hospital
Investigator: Yousif (Joe) H. Matloub
Contact: Yousif (Joe) H. Matloub Phone: 216-844-5437
Email not avaialable

Dayton, Ohio
Facility: Dayton Children's Hospital
Investigator: Ayman A. El-Sheikh
Contact: Ayman A. El-Sheikh Phone: 937-641-3296
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Oklahoma City, Oklahoma
Facility: University of Oklahoma Health Sciences Center
Investigator: Rene Y. McNall-Knapp
Contact: Rene Y. McNall-Knapp Phone: 405-271-8777
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Portland, Oregon
Facility: Oregon Health and Science University
Investigator: Kellie J. Nazemi
Contact: Kellie J. Nazemi Phone: 503-494-1080
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Hershey, Pennsylvania
Facility: Penn State Hershey Children's Hospital
Investigator: Lisa M. McGregor
Contact: Lisa M. McGregor Phone: 717-531-4787
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Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator: Michael J. Fisher
Contact: Michael J. Fisher Phone: 215-590-4183
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Pittsburgh, Pennsylvania
Facility: Children's Hospital of Pittsburgh of UPMC
Investigator: Jean M. Tersak
Contact: Jean M. Tersak Phone: 412-692-7693
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Columbia, South Carolina
Facility: Palmetto Health Richland
Investigator: Ronnie W. Neuberg
Contact: Ronnie W. Neuberg Phone: 803-434-3680
Email not avaialable

Greenville, South Carolina
Facility: BI-LO Charities Children's Cancer Center
Investigator: Nichole L. Bryant
Contact: Nichole L. Bryant Phone: 864-241-6251
Email not avaialable

Sioux Falls, South Dakota
Facility: Sanford USD Medical Center - Sioux Falls
Investigator: Kayelyn J. Wagner
Contact: Kayelyn J. Wagner Phone: 605-328-1367
Email not avaialable

Memphis, Tennessee
Facility: St. Jude Children's Research Hospital
Investigator: Wayne L. Furman
Contact: Wayne L. Furman Phone: 901-521-9005
Click HERE to send email to this center

Nashville, Tennessee
Facility: Vanderbilt University/Ingram Cancer Center
Investigator: Adam Esbenshade
Contact: Adam Esbenshade Phone: 800-811-8480
Email not avaialable

Austin, Texas
Facility: Dell Children's Medical Center of Central Texas
Investigator: Amy C. Fowler
Contact: Amy C. Fowler Phone: 214-648-7097
Email not avaialable

Dallas, Texas
Facility: Medical City Dallas Hospital
Investigator: Stanton C. Goldman
Contact: Stanton C. Goldman Phone: 972-566-5588
Email not avaialable

Dallas, Texas
Facility: UT Southwestern/Simmons Cancer Center-Dallas
Investigator: Daniel C. Bowers
Contact: Daniel C. Bowers Phone: 214-648-7097
Email not avaialable

Fort Worth, Texas
Facility: Cook Children's Medical Center
Investigator: Jeffrey C. Murray
Contact: Jeffrey C. Murray Phone: 682-885-1713
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Houston, Texas
Facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Investigator: Jack M. Su
Contact: Jack M. Su Phone: 713-798-1354
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Salt Lake City, Utah
Facility: Primary Children's Hospital
Investigator: Phillip E. Barnette
Contact: Phillip E. Barnette Phone: 801-662-4707
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Norfolk, Virginia
Facility: Childrens Hospital-King's Daughters
Investigator: Eric J. Lowe
Contact: Eric J. Lowe Phone: 757-668-7243
Email not avaialable

Seattle, Washington
Facility: Seattle Children's Hospital
Investigator: Douglas S. Hawkins
Contact: Douglas S. Hawkins Phone: 866-987-2000
Email not avaialable

Spokane, Washington
Facility: Providence Sacred Heart Medical Center and Children's Hospital
Investigator: Judy L. Felgenhauer
Contact: Judy L. Felgenhauer Phone: 800-228-6618
Click HERE to send email to this center

Madison, Wisconsin
Facility: University of Wisconsin Hospital and Clinics
Investigator: Kenneth B. De Santes
Contact: Kenneth B. De Santes Phone: 715-422-7718
Email not avaialable

Milwaukee, Wisconsin
Facility: Children¿s Hospital of Wisconsin
Investigator: Jeffrey A. Knipstein
Contact: Jeffrey A. Knipstein Phone: 414-955-6543
Click HERE to send email to this center




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