- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00025064
Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkin's Lymphoma
Protocol For The Treatment Of Children And Adolescents With Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy.
PURPOSE: This phase II trial is studying how well combination chemotherapy regimens with or without radiation therapy or peripheral stem cell transplant works in treating children with Hodgkin's lymphoma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Radiación: radioterapia
- Droga: etopósido
- Droga: sulfato de vincristina
- Droga: cisplatino
- Droga: clorhidrato de doxorrubicina
- Procedimiento: trasplante de células madre de sangre periférica
- Droga: melfalán
- Droga: clorambucilo
- Droga: dacarbazina
- Droga: ifosfamida
- Droga: clorhidrato de procarbazina
- Droga: prednisolona
- Droga: sulfato de vinblastina
- Biológico: sulfato de bleomicina
Descripción detallada
OBJECTIVES:
- Determine whether the current survival figures are maintained and long-term sequelae of treatment are minimized in children or adolescents with stage I-III Hodgkin's lymphoma after receiving the following regimen, which reduces exposure to chemotherapy and radiotherapy: chlorambucil, vinblastine, prednisolone, and procarbazine (ChIVPP) and doxorubicin, bleomycin, vincristine, and dacarbazine (ABVD) with etoposide, prednisolone, ifosfamide, and cisplatin (EPIC), radiotherapy, high-dose melphalan, and/or autologous peripheral blood stem cell transplantation (APBSCT).
- Determine whether the survival figures are improved in children or adolescents with stage IV Hodgkin's lymphoma or inadequate response to initial therapy after receiving ChIVPP and ABVD with EPIC, radiotherapy, high-dose melphalan, and APBSCT.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment groups based on disease status.
- Group 1 (stage I disease): All patients with mixed cellularity and younger patients with any subtype are assigned to subgroup A. Older patients without mixed cellularity are assigned to subgroup A or B based on the decision of the physicians and patients/parents. Subgroup A: Patients receive 2 courses of the hybrid regimen. One course of the hybrid regimen comprises regimen ChIVPP followed by regimen ABVD. Regimen ChIVPP comprises vinblastine IV on days 1 and 8 and oral chlorambucil, oral procarbazine, and oral prednisolone (PRDL) daily on days 1-14. Regimen ABVD comprises doxorubicin IV over 6 hours, bleomycin IV over 15-30 minutes, vincristine IV, and dacarbazine IV over 15 minutes on days 1 and 14. Patients with relapsed disease receive etoposide IV over 1 hour on days 1-4, oral PRDL and ifosfamide IV over 1 hour on days 1-5, and cisplatin IV over 24 hours on day 10 (EPIC). Treatment with EPIC continues every 3 weeks for a total of 6 courses. Patients then undergo radiotherapy. Patients with poor response after radiotherapy receive consolidation with high-dose melphalan (L-PAM) IV over 30-90 minutes, followed at least 12 hours later by autologous peripheral blood stem cell transplantation (APBSCT) (if there is no bone marrow involvement at the time of relapse). Subgroup B: Patients not in subgroup A may either receive chemotherapy as outlined or radiotherapy depending on clinician and patient discussion. Patients with relapsed disease after radiotherapy receive 3 courses of the hybrid regimen. If relapse occurs outside the initial radiotherapy field, then further radiotherapy is administered.
- Group 2 (stage II or III disease): Patients receive 3 courses of the hybrid regimen. Patients with relapsed disease receive 4 courses of EPIC. Patients with complete remission (CR) or good partial remission (GPR) after the fourth course of EPIC receive 2 additional courses of EPIC followed by radiotherapy. Patients without CR or GPR after the fourth course of EPIC undergo radiotherapy followed by L-PAM and APBSCT as in group 1, subgroup A.
- Group 3 (stage IV or inadequate response to initial therapy): Patients receive 2 courses the hybrid regimen. Patients with CR or GPR after the second course of ABVD are assigned to subgroup C. Patients without CR or GPR after the second course of ABVD are assigned to subgroup D. Subgroup C: Patients receive 2 additional courses of the hybrid regimen. Patients with relapsed disease after the fourth course of ABVD receive 4 courses of EPIC followed by radiotherapy, L-PAM, and APBSCT as in group 1, subgroup A. Subgroup D: Patients receive 4 courses of EPIC followed by radiotherapy, L-PAM, and APBSCT as in group 1, subgroup A.
Patients are followed every 2 months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 260 patients (75 with stage I disease, 150 with stage II or III disease, and 35 with stage IV disease) will be accrued for this study within 5 years.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Dublin, Irlanda, 12
- Our Lady's Hospital For Sick Children
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England
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Birmingham, England, Reino Unido, B4 6NH
- Birmingham Children's Hospital
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Bristol, England, Reino Unido, BS2 8BJ
- Bristol Royal Hospital for Children
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Cambridge, England, Reino Unido, CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
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Leeds, England, Reino Unido, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, Reino Unido, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, Reino Unido, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, Reino Unido, WC1N 3JH
- Great Ormond Street Hospital for Children NHS Trust
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London, England, Reino Unido, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, Reino Unido, WIT 3AA
- Meyerstein Institute of Oncology at University College of London Hospitals
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Manchester, England, Reino Unido, M27 4HA
- Central Manchester and Manchester Children's University Hospitals NHS Trust
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Newcastle-Upon-Tyne, England, Reino Unido, NE7 7DN
- Newcastle Upon Tyne Hospitals NHS Trust
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Nottingham, England, Reino Unido, NG7 2UH
- Queen's Medical Centre
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Oxford, England, Reino Unido, 0X3 9DU
- Oxford Radcliffe Hospital
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Sheffield, England, Reino Unido, S10 2TH
- Children's Hospital - Sheffield
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Southampton, England, Reino Unido, SO16 6YD
- Southampton General Hospital
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Sutton, England, Reino Unido, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Northern Ireland
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Belfast, Northern Ireland, Reino Unido, BT12 6BE
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, Reino Unido, AB25 2ZN
- Aberdeen Royal Infirmary
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Edinburgh, Scotland, Reino Unido, EH9 1LF
- Royal Hospital for Sick Children
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Glasgow, Scotland, Reino Unido, G3 8SJ
- Royal Hospital for Sick Children
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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 proven Hodgkin's lymphoma
- Stage I-IV
- No posttransplantation Hodgkin's lymphoma
- Mediastinal syndrome allowed
PATIENT CHARACTERISTICS:
Age:
- Under 18 at diagnosis
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other previously treated malignancy
- No DNA repair defect syndromes
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Martin Hewitt, MD, BSc, FRCP, FRCPCH, Queen's Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Enfermedades linfáticas
- Trastornos inmunoproliferativos
- Linfoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antiinflamatorios
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Glucocorticoides
- Hormonas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Agentes Antineoplásicos Hormonales
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Agonistas mieloablativos
- Agentes antineoplásicos, fitogénicos
- Inhibidores de la topoisomerasa II
- Inhibidores de la topoisomerasa
- Antibióticos, Antineoplásicos
- Prednisolona
- Etopósido
- Ifosfamida
- Melfalán
- Doxorrubicina
- Doxorrubicina liposomal
- Vincristina
- Dacarbazina
- Bleomicina
- Vinblastina
- Procarbazina
- Clorambucilo
Otros números de identificación del estudio
- CCLG-HD-2000-02
- CDR0000068901 (Identificador de registro: PDQ (Physician Data Query))
- EU-20108
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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