- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00022451
Tipifarnib in Treating Young Patients With Refractory Leukemia
A Phase I Trial and Pharmacokinetic Study of R115777 in Pediatric Patients With Refractory Leukemia
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.
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canadá, H3T 1C5
- Hopital Sainte Justine
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal Children's Hospital at McGill University Health Center
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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California
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Duarte, California, Estados Unidos, 91010-3000
- City of Hope Comprehensive Cancer Center
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La Jolla, California, Estados Unidos, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, Estados Unidos, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, Estados Unidos, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, Estados Unidos, 92868
- Children's Hospital of Orange County
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San Francisco, California, Estados Unidos, 94143
- UCSF Comprehensive Cancer Center
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Stanford, California, Estados Unidos, 94305-5208
- Stanford Cancer Center at Stanford University Medical Center
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20010-2970
- Children's National Medical Center
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Florida
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Gainesville, Florida, Estados Unidos, 32610-0296
- Shands Cancer Center at the University of Florida Health Science Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
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Augusta, Georgia, Estados Unidos, 30912-4000
- MBCCOP-Medical College of Georgia Cancer Center
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Illinois
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Chicago, Illinois, Estados Unidos, 60614
- Children's Memorial Hospital - Chicago
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202-5225
- Riley Children Cancer Center at Riley Hospital for Children
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Health Sciences Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21231-7223
- Sidney kimmel comprehensive cancer center at johns hopkins
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Boston, Massachusetts, Estados Unidos, 02111
- Floating Hospital for Children
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0914
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, Estados Unidos, 48201
- Children's Hospital of Michigan
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Estados Unidos, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, Estados Unidos, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Cancer Center at Hackensack University Medical Center
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New Brunswick, New Jersey, Estados Unidos, 08901
- Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Estados Unidos, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229-3039
- Cincinnati Children's Hospital Medical Center
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Columbus, Ohio, Estados Unidos, 43205-2696
- Columbus Children's Hospital
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73126
- Oklahoma University Medical Center
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- CCOP - Columbia River Oncology Program
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104-4318
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, Estados Unidos, 15213-2583
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Hollings Cancer Center at Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105-2794
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Estados Unidos, 37232-6310
- Vanderbilt Children's Hospital
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Texas
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Dallas, Texas, Estados Unidos, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Houston, Texas, Estados Unidos, 77030-2399
- Texas Children's Cancer Center
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San Antonio, Texas, Estados Unidos, 78207
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Estados Unidos, 78229-3900
- MBCCOP - South Texas Pediatrics
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Temple, Texas, Estados Unidos, 76508
- CCOP - Scott and White Hospital
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Children's Hospital and Regional Medical Center - Seattle
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Marshfield, Wisconsin, Estados Unidos, 54449
- CCOP - Marshfield Clinic Research Foundation
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Midwest Children's Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- leucemia mielomonocítica juvenil
- leucemia mieloide cronica infantil
- leucemia mielógena crónica en fase blástica
- leucemia mielógena crónica recidivante
- leucemia mielógena crónica, BCR-ABL1 positivo
- leucemia linfoblástica aguda infantil recurrente
- leucemia mieloide aguda infantil recurrente
- leucemia aguda indiferenciada
- leucemia promielocítica aguda infantil (M3)
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 010196
- 01-C-0196C
- COG-ADVL0116
- NCI-1930
- CDR0000068819
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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