- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00060255
High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Procedimiento: trasplante de células madre de sangre periférica
- Droga: busulfan
- Droga: carboplatin
- Droga: carmustine
- Droga: cyclophosphamide
- Droga: etoposide
- Droga: melphalan
- Droga: thiotepa
- Procedimiento: autologous bone marrow transplantation
- Procedimiento: bone marrow ablation with stem cell support
- Radiación: radiation therapy
Descripción detallada
OBJECTIVES:
- Determine the morbidity, mortality, and overall outcome in patients with hematologic malignancies, breast cancer, or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation.
OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk includes acute leukemia in first relapse or second remission; lymphoma in responding first relapse or second remission; or breast cancer at risk for recurrence. High risk includes all others. Patients receive specific conditioning regimens according to diagnosis as outlined below.
Conditioning
- Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide, cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4. Patients undergo TBI on days -3 to -1.
- Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide, carmustine, and etoposide (CBV): Patients receive etoposide IV continuously over 34 hours beginning on day -8; cyclophosphamide IV over 2 hours on days -7 to -4; and carmustine IV over 2 hours on day -3.
- Regimen C (any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
- Regimen D (multiple myeloma or amyloidosis)-Melphalan only (MEL only): Patients receive melphalan IV over 30 minutes on day -2.
- Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
- Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
- Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6.
- Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4.
Stem Cell Infusion
- In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen) will be accrued for this study within 10 years.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Buffalo, New York, Estados Unidos, 14263-0001
- Roswell Park Cancer Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic or solid tumor malignancy, including any of the following:
Acute myeloid leukemia
- First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission
- Not eligible for protocol CLB-9620 or CLB-9621
Acute lymphoblastic leukemia
- First complete remission without appropriate allogeneic donor
Chronic myelogenous leukemia
- Chronic, accelerated, or blast phase
Lymphoproliferative diseases*
- Chronic lymphocytic leukemia
- Multiple myeloma
- Waldenstrom's macroglobulinemia
- Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently
Amyloidosis
- Primary or previously treated disease
NHL (intermediate- and high-grade)
- Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse
- CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L
Hodgkin's lymphoma
- Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
Solid tumors
- High-risk and metastatic breast cancer
- Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy
- Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity
- Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged)
Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:
- Over 60 years of age
- No compatible donor identified
- Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation
- Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens
Hormone receptor status:
- Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 4 and over (patients 60 years of age and over are not eligible for TBI)
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 2 months
Hematopoietic
- WBC greater than 3,000/mm^3*
- Polymorphonuclear leukocyte count greater than 1,500/mm^3*
- Platelet count greater than 75,000/mm^3*
- Marrow cellularity greater than 20%*
- No marrow fibrosis* NOTE: *Before marrow storage
Hepatic
- Bilirubin less than 3 times normal
- Alkaline phosphatase less than 3 times normal
- AST less than 3 times normal
- Hepatitis status known
Renal
- Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma)
Cardiovascular
- Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No symptomatic angina
- No life-threatening arrhythmia or hypertension
Pulmonary
- DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation)
Other
- Not pregnant
- HIV negative
- Cytomegalovirus status known
- No active bacterial, viral, or fungal infection
- No active peptic ulcer disease
- No uncontrolled diabetes mellitus
- No serious organ dysfunction unless it is caused by the underlying disease
- No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
- No prior cumulative nitrosourea dose greater than 600 mg/m^2
- No prior cumulative bleomycin dose greater than 150 units/m^2
- No prior cumulative doxorubicin dose greater than 450 mg/m^2
- No prior cumulative daunorubicin dose greater than 600 mg/m^2
- Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy (before blood stem cell harvest)
Prior cumulative doses of radiotherapy must not exceed the following:
- Spine/spinal cord: 4,000 cGy
- Mediastinum: 4,000 cGy
- Heart: 4,000 cGy
- Kidney (whole): 1,500 cGy
- Small bowel: 4,000 cGy
- Brain: 4,000 cGy
- Liver (whole): 2,000 cGy
- Lungs (whole): 1,500 cGy
- Bone: 5,000 cGy
Surgery
- Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Morbidity
Periodo de tiempo: +day 100
|
+day 100
|
Mortality
Periodo de tiempo: +day 100, +day 360
|
+day 100, +day 360
|
Overall outcome
Periodo de tiempo: every 6 months until death
|
every 6 months until death
|
Response rate
Periodo de tiempo: +day 100, +day 360
|
+day 100, +day 360
|
Toxicity
Periodo de tiempo: +day100, +day 360
|
+day100, +day 360
|
Disease-free survival
Periodo de tiempo: up to 15years
|
up to 15years
|
Overall survival
Periodo de tiempo: every 6 months until death
|
every 6 months until death
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Philip L. McCarthy, MD, Roswell Park Cancer Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
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
- tumor sólido infantil no especificado, protocolo específico
- cáncer de mama en estadio IV
- cáncer de mama en estadio IIIA
- cáncer de mama recurrente
- cáncer de mama en estadio IIIB
- tumor sólido adulto no especificado, protocolo específico
- cáncer de mama masculino
- cáncer de mama en estadio IIIC
- linfoma folicular grado 3 recurrente
- Linfoma difuso de células grandes en adultos recidivante
- Linfoma inmunoblástico de células grandes en adultos recidivante
- Linfoma de Burkitt en adultos recidivante
- Linfoma de células pequeñas no hendidas infantil recidivante
- linfoma de células grandes infantil recurrente
- leucemia mieloide aguda en adultos con anomalías 11q23 (MLL)
- leucemia mieloide aguda en adultos con inv(16)(p13;q22)
- leucemia mieloide aguda en adultos con t(15;17)(q22;q12)
- leucemia mieloide aguda en adultos con t(16;16)(p13;q22)
- leucemia mieloide aguda en adultos con t(8;21)(q22;q22)
- leucemia linfoblástica aguda infantil en remisión
- leucemia mieloide aguda infantil en remisión
- leucemia mielógena crónica en fase crónica
- leucemia mieloide cronica infantil
- amiloidosis sistémica primaria
- leucemia mieloide aguda recurrente en adultos
- leucemia mieloide crónica atípica
- leucemia mieloide aguda del adulto en remisión
- linfoma de Hodgkin adulto recurrente
- Linfoma de Hodgkin infantil recurrente/refractario
- Linfoma difuso de células pequeñas hendidas en adultos recidivante
- Linfoma difuso de células mixtas en adultos recidivante
- leucemia mielógena crónica en fase blástica
- Macroglobulinemia de Waldenström
- linfoma folicular grado 1 recurrente
- linfoma folicular grado 2 recurrente
- linfoma de la zona marginal recurrente
- linfoma de linfocitos pequeños recurrente
- Linfoma extraganglionar de células B de la zona marginal de tejido linfoide asociado a mucosas
- linfoma de células B de la zona marginal ganglionar
- linfoma esplénico de la zona marginal
- linfoma de células del manto recurrente
- leucemia linfocítica crónica refractaria
- mieloma múltiple refractario
- leucemia mielógena crónica en fase acelerada
- leucemia linfoblástica aguda del adulto en remisión
- leucemia mieloide aguda infantil recurrente
- linfoma linfoblástico infantil recurrente
- Tumor testicular maligno de células germinativas recurrente
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades de la piel
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Neoplasias por sitio
- Enfermedades hematológicas
- Enfermedades de los senos
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Neoplasias
- Linfoma
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias de mama
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Leucemia
- Plasmacitoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antirreumáticos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Ciclofosfamida
- Carboplatino
- Etopósido
- Melfalán
- Tiotepa
- Busulfán
- Carmustina
Otros números de identificación del estudio
- CDR0000301587
- RPCI-DS-9115
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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