Spots Global Cancer Trial Database for Tipifarnib in Treating Young Patients With Refractory Leukemia
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Trial Identification
Brief Title: Tipifarnib in Treating Young Patients With Refractory Leukemia
Official Title: A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
Study ID: NCT00022451
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
Children's Hospital of Orange County, Orange, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center, Stanford, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Shands Cancer Center at the University of Florida Health Science Center, Gainesville, Florida, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, United States
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
Riley Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Floating Hospital for Children, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital, Saint Louis, Missouri, United States
St. Louis Children's Hospital, Saint Louis, Missouri, United States
Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Columbus Children's Hospital, Columbus, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
Vanderbilt Children's Hospital, Nashville, Tennessee, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Texas Children's Cancer Center, Houston, Texas, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
MBCCOP - South Texas Pediatrics, San Antonio, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Hospital for Sick Children, Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Contact Details
Name: Brigitte C. Widemann, MD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR
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