- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00016939
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase II Study of Flavopiridol 1 Hour Bolus Days 1-3 Q 21 Days in Patients With Advanced Renal Cell Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have unresectable or metastatic kidney cancer.
Descripción general del estudio
Descripción detallada
OBJECTIVES:
- Determine the confirmed and unconfirmed complete and partial responses in patients with unresectable or metastatic renal cell cancer treated with flavopiridol.
- Determine the 6-month time to treatment failure rate and overall survival rate of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in this patient population.
- Determine, in a preliminary manner, the association of tumor response with pretreatment tumor proliferative and apoptotic rates in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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Mobile, Alabama, Estados Unidos, 36688
- MBCCOP - Gulf Coast
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006-2726
- CCOP - Greater Phoenix
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Phoenix, Arizona, Estados Unidos, 85012
- Veterans Affairs Medical Center - Phoenix (Hayden)
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Cancer Center
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Tucson, Arizona, Estados Unidos, 85723
- Veterans Affairs Medical Center - Tucson
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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Little Rock, Arkansas, Estados Unidos, 72205
- Veterans Affairs Medical Center - Little Rock (McClellan)
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California
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Duarte, California, Estados Unidos, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
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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, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
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Los Angeles, California, Estados Unidos, 90073
- Veterans Affairs Medical Center - West Los Angeles
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Martinez, California, Estados Unidos, 94553
- Veterans Affairs Outpatient Clinic - Martinez
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Oakland, California, Estados Unidos, 94609-3305
- CCOP - Bay Area Tumor Institute
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Orange, California, Estados Unidos, 92868
- Chao Family Comprehensive Cancer Center
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Medical Center
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Cancer Center
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San Francisco, California, Estados Unidos, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, Estados Unidos, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Santa Rosa, California, Estados Unidos, 95403
- CCOP - Santa Rosa Memorial Hospital
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Travis Air Force Base, California, Estados Unidos, 94535
- David Grant Medical Center
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Colorado
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Denver, Colorado, Estados Unidos, 80220
- Veterans Affairs Medical Center - Denver
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Denver, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342-1701
- CCOP - Atlanta Regional
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Fort Gordon, Georgia, Estados Unidos, 30905-5650
- Dwight David Eisenhower Army Medical Center
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- Cancer Research Center of Hawaii
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Illinois
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Chicago, Illinois, Estados Unidos, 60612-7323
- MBCCOP - University of Illinois at Chicago
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Chicago, Illinois, Estados Unidos, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Decatur, Illinois, Estados Unidos, 62526
- CCOP - Central Illinois
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Hines, Illinois, Estados Unidos, 60141
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Wichita, Kansas, Estados Unidos, 67218
- Veterans Affairs Medical Center - Wichita
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40511-1093
- Veterans Affairs Medical Center - Lexington
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Lexington, Kentucky, Estados Unidos, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University School of Medicine
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New Orleans, Louisiana, Estados Unidos, 70112
- Veterans Affairs Medical Center - New Orleans
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New Orleans, Louisiana, Estados Unidos, 70112
- MBCCOP - LSU Health Sciences Center
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Shreveport, Louisiana, Estados Unidos, 71130-3932
- Louisiana State University Health Sciences Center - Shreveport
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Shreveport, Louisiana, Estados Unidos, 71130
- Veterans Affairs Medical Center - Shreveport
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Jamaica Plain, Massachusetts, Estados Unidos, 02130
- Veterans Affairs Medical Center - Boston (Jamaica Plain)
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Ann Arbor, Michigan, Estados Unidos, 48105
- Veterans Affairs Medical Center - Ann Arbor
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Ann Arbor Regional
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Detroit, Michigan, Estados Unidos, 48201-1932
- Veterans Affairs Medical Center - Detroit
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Grand Rapids, Michigan, Estados Unidos, 49503
- CCOP - Grand Rapids Clinical Oncology Program
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Southfield, Michigan, Estados Unidos, 48075-9975
- Providence Hospital - Southfield
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Mississippi
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Biloxi, Mississippi, Estados Unidos, 39531-2410
- Veterans Affairs Medical Center - Biloxi
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Jackson, Mississippi, Estados Unidos, 39216-4505
- University of Mississippi Medical Center
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Jackson, Mississippi, Estados Unidos, 39216
- Veterans Affairs Medical Center - Jackson
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Keesler AFB, Mississippi, Estados Unidos, 39534-2576
- Keesler Medical Center - Keesler AFB
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Missouri
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Kansas City, Missouri, Estados Unidos, 64128
- Veterans Affairs Medical Center - Kansas City
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Kansas City, Missouri, Estados Unidos, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Estados Unidos, 63110-0250
- St. Louis University Health Sciences Center
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Saint Louis, Missouri, Estados Unidos, 63141
- CCOP - St. Louis-Cape Girardeau
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Springfield, Missouri, Estados Unidos, 65807
- CCOP - Cancer Research for the Ozarks
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Montana
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Billings, Montana, Estados Unidos, 59101
- CCOP - Montana Cancer Consortium
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87108-5138
- Veterans Affairs Medical Center - Albuquerque
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Albuquerque, New Mexico, Estados Unidos, 87131
- MBCCOP - University of New Mexico HSC
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New York
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Albany, New York, Estados Unidos, 12208
- Veterans Affairs Medical Center - Albany
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New York, New York, Estados Unidos, 10032
- Herbert Irving Comprehensive Cancer Center
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45220-2288
- Veterans Affairs Medical Center - Cincinnati
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Cincinnati, Ohio, Estados Unidos, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, Estados Unidos, 43206
- CCOP - Columbus
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Dayton, Ohio, Estados Unidos, 45428
- Veterans Affairs Medical Center - Dayton
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Kettering, Ohio, Estados Unidos, 45429
- CCOP - Dayton
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Toledo, Ohio, Estados Unidos, 43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Oklahoma Medical Research Foundation
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- Veterans Affairs Medical Center - Oklahoma City
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Oregon
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Portland, Oregon, Estados Unidos, 97207
- Veterans Affairs Medical Center - Portland
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Portland, Oregon, Estados Unidos, 97213
- CCOP - Columbia River Program
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Portland, Oregon, Estados Unidos, 97201-3098
- Oregon Cancer Center
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425-0721
- Medical University of South Carolina
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Charleston, South Carolina, Estados Unidos, 29401-5799
- Veterans Affairs Medical Center - Charleston
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Greenville, South Carolina, Estados Unidos, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, Estados Unidos, 29303
- CCOP - Upstate Carolina
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Texas
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Fort Sam Houston, Texas, Estados Unidos, 78234
- Brooke Army Medical Center
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Galveston, Texas, Estados Unidos, 77555-0209
- University of Texas Medical Branch
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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Houston, Texas, Estados Unidos, 77030
- Veterans Affairs Medical Center - Houston
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Lubbock, Texas, Estados Unidos, 79415
- Texas Tech University Health Science Center
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San Antonio, Texas, Estados Unidos, 78284-7811
- University of Texas Health Science Center at San Antonio
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San Antonio, Texas, Estados Unidos, 78284
- Veterans Affairs Medical Center - San Antonio (Murphy)
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Temple, Texas, Estados Unidos, 76504
- Veterans Affairs Medical Center - Temple
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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, 84148
- Veterans Affairs Medical Center - Salt Lake City
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Eastern Virginia Medical School
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Washington
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Seattle, Washington, Estados Unidos, 98101
- CCOP - Virginia Mason Research Center
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Seattle, Washington, Estados Unidos, 98104
- Swedish Cancer Institute
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Seattle, Washington, Estados Unidos, 98108
- Veterans Affairs Medical Center - Seattle
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Tacoma, Washington, Estados Unidos, 98431-5000
- Madigan Army Medical Center
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Tacoma, Washington, Estados Unidos, 98405-0986
- CCOP - Northwest
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed unresectable primary (M0) or metastatic renal cell cancer
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- Soft tissue disease that has been previously irradiated within the past 2 months is not considered measurable
- Soft tissue disease within a previously irradiated field is considered measurable provided disease has progressed and other measurable disease exists outside of the radiation field
- No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- No hypercoagulable state other than renal cell cancer
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No prior isolated occurrence of deep venous thrombosis within the past 6 months
Pulmonary:
- No prior isolated occurrence of pulmonary embolism within the past 6 months
Other:
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission
- No history of allergic reactions to compounds of similar chemical or biologic composition to flavopiridol (e.g., staurosporine, deschloroflavopiridol, or butyrolactone I)
- No other uncontrolled illness (e.g., diabetes mellitus)
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- 1 prior immunotherapy regimen comprising interferon and/or interleukin-2 allowed
- At least 28 days since prior immunotherapy and recovered
- No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
- No prior chemotherapy for renal cell cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- At least 21 days since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
- Prior resection of primary tumor allowed
- At least 28 days since prior surgery and recovered
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Peter J. VanVeldhuizen, MD, Kansas City Veteran Affairs Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria
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
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias Urológicas
- Neoplasias urogenitales
- Neoplasias por sitio
- Enfermedades Renales
- Enfermedades urológicas
- Adenocarcinoma
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Renales
- Carcinoma De Célula Renal
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Sustancias de crecimiento
- Inhibidores del crecimiento
- Inhibidores de la proteína quinasa
- Alvocidib
Otros números de identificación del estudio
- CDR0000068634
- SWOG-S0109
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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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