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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response - best response
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.
Up to 5 years
No
Katherine Warren
Principal Investigator
Children's Oncology Group
United States: Food and Drug Administration
NCI-2012-00703
NCT01553149
March 2012
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Nationwide Children's Hospital | Columbus, Ohio 43205-2696 |
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
Lee Memorial Health System | Fort Myers, Florida 33902 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
Children's Hospital of Alabama | Birmingham, Alabama 35233 |
Connecticut Children's Medical Center | Hartford, Connecticut 06106 |
Nemours Children's Clinic - Pensacola | Pensacola, Florida 32504 |
Wayne State University | Detroit, Michigan 48202 |
BI-LO Charities Children's Cancer Center | Greenville, South Carolina 29605 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Oregon Health and Science University | Portland, Oregon 97201 |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Seattle Children's Hospital | Seattle, Washington 98105 |
Childrens Memorial Hospital | Chicago, Illinois 60614 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Vincent Hospital and Health Services | Indianapolis, Indiana 46260 |
Michigan State University - Breslin Cancer Center | East Lansing, Michigan 48824-1313 |
Saint John's Mercy Medical Center | Saint Louis, Missouri 63141 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
New York University Langone Medical Center | New York, New York 10016 |
Columbia University Medical Center | New York, New York 10032 |
State University of New York Upstate Medical University | Syracuse, New York 13210 |
University of Illinois | Chicago, Illinois 60612 |
Cook Children's Medical Center | Fort Worth, Texas 76104 |
The Children's Medical Center of Dayton | Dayton, Ohio 45404 |
C S Mott Children's Hospital | Ann Arbor, Michigan 48109 |
Riley Hospital for Children | Indianapolis, Indiana 46202 |
UMDNJ - Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Miller Children's Hospital | Long Beach, California 90806 |
Childrens Hospital of Orange County | Orange, California 92868-3874 |
Alfred I duPont Hospital for Children | Wilmington, Delaware 19803 |
Nemours Children's Clinic - Jacksonville | Jacksonville, Florida 32207-8426 |
Nemours Childrens Clinic - Orlando | Orlando, Florida 32806 |
Children's Healthcare of Atlanta - Egleston | Atlanta, Georgia 30322 |
The Childrens Mercy Hospital | Kansas City, Missouri 64108 |
Rainbow Babies and Childrens Hospital | Cleveland, Ohio 44106 |
Penn State Hershey Children's Hospital | Hershey, Pennsylvania 17033 |
Palmetto Health Richland | Columbia, South Carolina 29203 |
Childrens Hospital-King's Daughters | Norfolk, Virginia 23507 |
Mark O Hatfield-Warren Grant Magnuson Clinical Center | Bethesda, Maryland 20892 |
Lucile Packard Children's Hospital Stanford University | Palo Alto, California 94304 |
University of California San Francisco Medical Center-Parnassus | San Francisco, California 94143 |
Raymond Blank Children's Hospital | Des Moines, Iowa 50309 |
Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota 57117-5134 |
Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington 99204 |