Tipifarnib in Treating Young Patients With Refractory Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT00022451
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
🇺🇸Atlanta, Georgia, United States
Floating Hospital for Children
🇺🇸Boston, Massachusetts, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Cancer Center at Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Royal Children's Hospital
🇦🇺Parkville, Victoria, Australia
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Riley Children Cancer Center at Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
🇺🇸Bethesda, Maryland, United States
University of Minnesota Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, 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
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, 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
MBCCOP-Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, 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
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada