Fact CheckerSign in

NCT01553149CompletedPhase 2

Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma

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

Source: ClinicalTrials.gov · Last updated 7 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
75 (actual)
First submitted
10 Mar 2012
Start date
5 Jul 2012
Primary completion date
30 Jun 2020
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT01553149

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 75
  • From 5 Jul 2012 to the primary completion date, 30 Jun 2020
  • 126 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • 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

Other

  • Female patients who are pregnant are not eligible
  • 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

Who the study is looking for

  • 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

Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (126)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Brisbane and Women's Hospital
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status
Royal Children's Hospital-Brisbane
Coordinator of this site? Confirm its status
HerstonAustraliaUnknown status
Royal Children's Hospital
Coordinator of this site? Confirm its status
ParkvilleAustraliaUnknown status
Princess Margaret Hospital for Children
Coordinator of this site? Confirm its status
PerthAustraliaUnknown status
Queensland Children's Hospital
Coordinator of this site? Confirm its status
South BrisbaneAustraliaUnknown status
IWK Health Centre
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
McMaster Children's Hospital at Hamilton Health Sciences
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Kingston Health Sciences Centre
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
Centre Hospitalier Universitaire Sainte-Justine
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
The Montreal Children's Hospital of the MUHC
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
British Columbia Children's Hospital
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
Christchurch Hospital
Coordinator of this site? Confirm its status
ChristchurchNew ZealandUnknown status
Starship Children's Hospital
Coordinator of this site? Confirm its status
GraftonNew ZealandUnknown status
Children's Hospital Medical Center of Akron
Coordinator of this site? Confirm its status
AkronUnited StatesUnknown status
University of New Mexico Cancer Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
C S Mott Children's Hospital
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
Children's Healthcare of Atlanta-Egleston
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Dell Children's Medical Center of Central Texas
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
National Institutes of Health Clinical Center
Coordinator of this site? Confirm its status
BethesdaUnited StatesUnknown status
Children's Hospital of Alabama
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
University of Alabama at Birmingham Cancer Center
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
Coordinator of this site? Confirm its status
BoiseUnited StatesUnknown status
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Roswell Park Cancer Institute
Coordinator of this site? Confirm its status
BuffaloUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Chapel HillUnited StatesUnknown status
Medical University of South Carolina
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
Carolinas Medical Center/Levine Cancer Institute
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Illinois
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Lurie Children's Hospital-Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Rainbow Babies and Childrens Hospital
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Columbia Regional
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Prisma Health Richland Hospital
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Driscoll Children's Hospital
Coordinator of this site? Confirm its status
Corpus ChristiUnited StatesUnknown status
Medical City Dallas Hospital
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
UT Southwestern/Simmons Cancer Center-Dallas
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Dayton Children's Hospital
Coordinator of this site? Confirm its status
DaytonUnited StatesUnknown status
Blank Children's Hospital
Coordinator of this site? Confirm its status
Des MoinesUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Kaiser Permanente Downey Medical Center
Coordinator of this site? Confirm its status
DowneyUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
Michigan State University Clinical Center
Coordinator of this site? Confirm its status
East LansingUnited StatesUnknown status
Lee Memorial Health System
Coordinator of this site? Confirm its status
Fort MyersUnited StatesUnknown status
Golisano Children's Hospital of Southwest Florida
Coordinator of this site? Confirm its status
Fort MyersUnited StatesUnknown status
Cook Children's Medical Center
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
University of Florida Health Science Center - Gainesville
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
Helen DeVos Children's Hospital at Spectrum Health
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesUnknown status
BI-LO Charities Children's Cancer Center
Coordinator of this site? Confirm its status
GreenvilleUnited StatesUnknown status
East Carolina University
Coordinator of this site? Confirm its status
GreenvilleUnited StatesUnknown status
Hackensack University Medical Center
Coordinator of this site? Confirm its status
HackensackUnited StatesUnknown status
Connecticut Children's Medical Center
Coordinator of this site? Confirm its status
HartfordUnited StatesUnknown status
Penn State Children's Hospital
Coordinator of this site? Confirm its status
HersheyUnited StatesUnknown status
University of Hawaii Cancer Center
Coordinator of this site? Confirm its status
HonoluluUnited StatesUnknown status
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Riley Hospital for Children
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Ascension Saint Vincent Indianapolis Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
University of Mississippi Medical Center
Coordinator of this site? Confirm its status
JacksonUnited StatesUnknown status
Nemours Children's Clinic-Jacksonville
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Children's Mercy Hospitals and Clinics
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
East Tennessee Childrens Hospital
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
Summerlin Hospital Medical Center
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Nevada Cancer Research Foundation NCORP
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Coordinator of this site? Confirm its status
LebanonUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
Arkansas Children's Hospital
Coordinator of this site? Confirm its status
Little RockUnited StatesUnknown status
Loma Linda University Medical Center
Coordinator of this site? Confirm its status
Loma LindaUnited StatesUnknown status
Miller Children's and Women's Hospital Long Beach
Coordinator of this site? Confirm its status
Long BeachUnited StatesUnknown status
Children's Hospital Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Cedars-Sinai Medical Center
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Norton Children's Hospital
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Valley Children's Hospital
Coordinator of this site? Confirm its status
MaderaUnited StatesUnknown status
University of Wisconsin Carbone Cancer Center
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status
Loyola University Medical Center
Coordinator of this site? Confirm its status
MaywoodUnited StatesUnknown status
Saint Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Children's Hospital of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota - Minneapolis
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Morristown Medical Center
Coordinator of this site? Confirm its status
MorristownUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Ochsner Medical Center Jefferson
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Tulane University School of Medicine
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Children's Hospital New Orleans
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Children's Hospital of The King's Daughters
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
Kaiser Permanente-Oakland
Coordinator of this site? Confirm its status
OaklandUnited StatesUnknown status
Advocate Children's Hospital-Oak Lawn
Coordinator of this site? Confirm its status
Oak LawnUnited StatesUnknown status
University of Oklahoma Health Sciences Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Children's Hospital and Medical Center of Omaha
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
Children's Hospital of Orange County
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Nemours Children's Hospital
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Nemours Children's Clinic - Orlando
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
AdventHealth Orlando
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Arnold Palmer Hospital for Children
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Lucile Packard Children's Hospital Stanford University
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
Nemours Children's Clinic - Pensacola
Coordinator of this site? Confirm its status
PensacolaUnited StatesUnknown status
Saint Jude Midwest Affiliate
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Phoenix Childrens Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Children's Hospital of Pittsburgh of UPMC
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Oregon Health and Science University
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Sutter Medical Center Sacramento
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Primary Children's Hospital
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
UCSF Medical Center-Parnassus
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
UCSF Medical Center-Mission Bay
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Memorial Health University Medical Center
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesUnknown status
Providence Sacred Heart Medical Center and Children's Hospital
Coordinator of this site? Confirm its status
SpokaneUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Cardinal Glennon Children's Medical Center
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Mercy Hospital Saint Louis
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Johns Hopkins All Children's Hospital
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesUnknown status
State University of New York Upstate Medical University
Coordinator of this site? Confirm its status
SyracuseUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Mercy Children's Hospital
Coordinator of this site? Confirm its status
ToledoUnited StatesUnknown status
New York Medical College
Coordinator of this site? Confirm its status
ValhallaUnited StatesUnknown status
Children's National Medical Center
Coordinator of this site? Confirm its status
Washington D.C.United StatesUnknown status
Alfred I duPont Hospital for Children
Coordinator of this site? Confirm its status
WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.