Tipifarnib in Treating Young Patients With Refractory Leukemia
NCT ID: NCT00022451
Last Updated: 2012-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2001-06-30
2005-03-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of tipifarnib in treating young patients who have refractory leukemia.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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tipifarnib
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed acute lymphoblastic leukemia, acute nonlymphoblastic leukemia, juvenile myelomonocytic leukemia (JMML), or chronic myelogenous leukemia (CML) in blast crisis
* Refractory to standard curative therapy
* Acute promyelocytic leukemia refractory to tretinoin and arsenic trioxide
* Philadelphia chromosome-positive CML refractory to imatinib mesylate
* Greater than 25% blasts in bone marrow (M3 bone marrow) except for patients with JMML
* Active extramedullary disease allowed
* No active leptomeningeal leukemia
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* Karnofsky 50-100% (over 10 years of age)
* Lansky 50-100% (10 years of age and under)
Life expectancy:
* Not specified
Hematopoietic:
* Not required to be normal
Hepatic:
* Bilirubin normal
* SGPT and SGOT normal
* No significant hepatic dysfunction
* No grade 3 or 4 liver function test results within the past month
Renal:
* Creatinine normal OR
* Creatinine clearance at least 60 mL/min
* No significant renal dysfunction
Cardiovascular:
* No significant cardiac dysfunction
Pulmonary:
* No significant pulmonary dysfunction
Neurologic:
* No history of grand mal seizures grade 3 or greater except febrile seizures
* No persistent sensory or motor neuropathy greater than grade 2
Other:
* No clinically significant unrelated systemic illness
* No serious infection
* No organ dysfunction that would preclude study participation
* No requirement for total parenteral nutrition
* No known allergy to azoles (e.g., clotrimazole, fluconazole, ketoconazole, voriconazole)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior colony-stimulating factor therapy (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) except epoetin alfa
* At least 3 months since prior myeloablative therapy followed by bone marrow or stem cell transplantation
* No concurrent immunotherapy
* No concurrent GM-CSF or interleukin-11
Chemotherapy:
* At least 2 weeks since prior chemotherapy
* No concurrent intrathecal chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* At least 1 week since prior corticosteroids
* No concurrent corticosteroids (except for acute allergic reaction)
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* Recovered from nonhematologic toxicity of all prior therapy
* At least 1 week since prior retinoids
* No antacids (magnesium- or aluminum-containing formulations) within 2 hours of study drug
* No other concurrent investigational agents
* No concurrent retinoids
* No concurrent anticonvulsants
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
National Institutes of Health Clinical Center (CC)
NIH
Principal Investigators
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Brigitte C. Widemann, MD
Role: STUDY_CHAIR
National Cancer Institute (NCI)
Locations
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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 D.C., 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
St Louis, Missouri, United States
St. Louis Children's Hospital
St 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
Countries
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References
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de Nigris F, Balestrieri ML, Napoli C. Targeting c-Myc, Ras and IGF cascade to treat cancer and vascular disorders. Cell Cycle. 2006 Aug;5(15):1621-8. doi: 10.4161/cc.5.15.3138. Epub 2006 Aug 1.
Widemann BC, Arceci RJ, Jayaprakash N, Fox E, Zannikos P, Goodspeed W, Goodwin A, Wright JJ, Blaney SM, Adamson PC, Balis FM. Phase 1 trial and pharmacokinetic study of the farnesyl transferase inhibitor tipifarnib in children and adolescents with refractory leukemias: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Feb;56(2):226-33. doi: 10.1002/pbc.22775. Epub 2010 Sep 21.
Other Identifiers
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01-C-0196C
Identifier Type: -
Identifier Source: secondary_id
COG-ADVL0116
Identifier Type: -
Identifier Source: secondary_id
NCI-1930
Identifier Type: -
Identifier Source: secondary_id
CDR0000068819
Identifier Type: -
Identifier Source: secondary_id
010196
Identifier Type: -
Identifier Source: org_study_id
NCT00017888
Identifier Type: -
Identifier Source: nct_alias
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