A Phase II Randomized Trial of Lenalidomide (NSC # 703813) in Pediatric Patients With Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas

Who is this study for? Patients with Glioma
What treatments are being studied? Lenalidomide+Pharmacological Study
Status: Completed
Location: See all (126) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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 is classified as an immunomodulatory drug as it boosts the immune system. It has other potential anti-tumor effects, for example, it 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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: f
View:

• 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)

⁃ 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

Locations
United States
Alabama
Children's Hospital of Alabama
Birmingham
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
Arkansas Children's Hospital
Little Rock
University of Arkansas for Medical Sciences
Little Rock
Arizona
Phoenix Childrens Hospital
Phoenix
California
Kaiser Permanente Downey Medical Center
Downey
City of Hope Comprehensive Cancer Center
Duarte
Loma Linda University Medical Center
Loma Linda
Miller Children's and Women's Hospital Long Beach
Long Beach
Cedars Sinai Medical Center
Los Angeles
Children's Hospital Los Angeles
Los Angeles
Valley Children's Hospital
Madera
Kaiser Permanente-Oakland
Oakland
Children's Hospital of Orange County
Orange
Lucile Packard Children's Hospital Stanford University
Palo Alto
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
UCSF Medical Center-Mission Bay
San Francisco
UCSF Medical Center-Parnassus
San Francisco
Colorado
Children's Hospital Colorado
Aurora
Connecticut
Connecticut Children's Medical Center
Hartford
Washington, D.c.
Children's National Medical Center
Washington D.c.
Delaware
Alfred I duPont Hospital for Children
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
Fort Myers
Lee Memorial Health System
Fort Myers
University of Florida Health Science Center - Gainesville
Gainesville
Nemours Children's Clinic-Jacksonville
Jacksonville
AdventHealth Orlando
Orlando
Arnold Palmer Hospital for Children
Orlando
Nemours Children's Clinic - Orlando
Orlando
Nemours Children's Hospital
Orlando
Nemours Children's Clinic - Pensacola
Pensacola
Johns Hopkins All Children's Hospital
St. Petersburg
Georgia
Children's Healthcare of Atlanta - Egleston
Atlanta
Memorial Health University Medical Center
Savannah
Hawaii
University of Hawaii Cancer Center
Honolulu
Iowa
Blank Children's Hospital
Des Moines
Idaho
Saint Luke's Cancer Institute - Boise
Boise
Illinois
Lurie Children's Hospital-Chicago
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
University of Illinois
Chicago
Loyola University Medical Center
Maywood
Advocate Children's Hospital-Oak Lawn
Oak Lawn
Saint Jude Midwest Affiliate
Peoria
Indiana
Ascension Saint Vincent Indianapolis Hospital
Indianapolis
Riley Hospital for Children
Indianapolis
Kentucky
University of Kentucky/Markey Cancer Center
Lexington
Norton Children's Hospital
Louisville
Louisiana
Children's Hospital New Orleans
New Orleans
Ochsner Medical Center Jefferson
New Orleans
Tulane University School of Medicine
New Orleans
Massachusetts
Dana-Farber Cancer Institute
Boston
Maryland
National Institutes of Health Clinical Center
Bethesda
Michigan
C S Mott Children's Hospital
Ann Arbor
Wayne State University/Karmanos Cancer Institute
Detroit
Michigan State University Clinical Center
East Lansing
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids
Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis
Mayo Clinic in Rochester
Rochester
Missouri
Columbia Regional
Columbia
Children's Mercy Hospitals and Clinics
Kansas City
Cardinal Glennon Children's Medical Center
St Louis
Mercy Hospital Saint Louis
St Louis
Washington University School of Medicine
St Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Carolinas Medical Center/Levine Cancer Institute
Charlotte
East Carolina University
Greenville
Nebraska
Children's Hospital and Medical Center of Omaha
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon
New Jersey
Hackensack University Medical Center
Hackensack
Morristown Medical Center
Morristown
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas
Nevada Cancer Research Foundation NCORP
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
New York
Roswell Park Cancer Institute
Buffalo
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York
State University of New York Upstate Medical University
Syracuse
Montefiore Medical Center - Moses Campus
The Bronx
New York Medical College
Valhalla
Ohio
Children's Hospital Medical Center of Akron
Akron
Cincinnati Children's Hospital Medical Center
Cincinnati
Rainbow Babies and Childrens Hospital
Cleveland
Nationwide Children's Hospital
Columbus
Dayton Children's Hospital
Dayton
Mercy Children's Hospital
Toledo
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Penn State Children's Hospital
Hershey
Children's Hospital of Philadelphia
Philadelphia
Children's Hospital of Pittsburgh of UPMC
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Prisma Health Richland Hospital
Columbia
BI-LO Charities Children's Cancer Center
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
East Tennessee Childrens Hospital
Knoxville
Saint Jude Children's Research Hospital
Memphis
Vanderbilt University/Ingram Cancer Center
Nashville
Texas
Dell Children's Medical Center of Central Texas
Austin
Driscoll Children's Hospital
Corpus Christi
Medical City Dallas Hospital
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
Cook Children's Medical Center
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston
Utah
Primary Children's Hospital
Salt Lake City
Virginia
Children's Hospital of The King's Daughters
Norfolk
Washington
Seattle Children's Hospital
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
Spokane
Wisconsin
University of Wisconsin Carbone Cancer Center
Madison
Children's Hospital of Wisconsin
Milwaukee
Other Locations
Australia
Royal Brisbane and Women's Hospital
Herston
Royal Children's Hospital-Brisbane
Herston
Royal Children's Hospital
Parkville
Princess Margaret Hospital for Children
Perth
Queensland Children's Hospital
South Brisbane
Canada
IWK Health Centre
Halifax
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton
Kingston Health Sciences Centre
Kingston
Centre Hospitalier Universitaire Sainte-Justine
Montreal
The Montreal Children's Hospital of the MUHC
Montreal
British Columbia Children's Hospital
Vancouver
New Zealand
Christchurch Hospital
Christchurch
Starship Children's Hospital
Grafton
Time Frame
Start Date: 2012-07-05
Completion Date: 2023-12-31
Participants
Target number of participants: 75
Treatments
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.
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.
Authors
Katherine Warren
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov