A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
OBJECTIVES:
Primary
- Determine the maximum tolerated dose and toxicity profile of tipifarnib in pediatric
patients with refractory leukemia.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the toxicity profile of this drug in these patients.
Secondary
- Analyze the gene expression profile of leukemic blasts from these patients before and
after treatment with this drug.
- Determine circulating levels of nerve growth factor and correlate these levels with
clinical neurotoxicity from this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 6 patients experience dose-limiting toxicity. At least 9 additional patients are treated
at the MTD.
PROJECTED ACCRUAL: A total of 12-34 patients will be accrued for this study within 1-2
years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Brigitte C. Widemann, MD
Study Chair
National Cancer Institute (NCI)
United States: Federal Government
010196
NCT00022451
June 2001
March 2005
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Children's Hospital of Michigan | Detroit, Michigan 48201 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York, New York 10016 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
Children's Hospital of Orange County | Orange, California 92668 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Floating Hospital for Children | Boston, Massachusetts 02111 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
Texas Children's Cancer Center | Houston, Texas 77030-2399 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus | Atlanta, Georgia 30342 |
Shands Cancer Center at the University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
Riley Children Cancer Center at Riley Hospital for Children | Indianapolis, Indiana 46202-5225 |
Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Vanderbilt Children's Hospital | Nashville, Tennessee 37232-6310 |
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390-9063 |
MBCCOP - South Texas Pediatrics | San Antonio, Texas 78229-3900 |
Columbus Children's Hospital | Columbus, Ohio 43205-2696 |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |