- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Radiation: Radiothérapie
- Médicament: étoposide
- Médicament: sulfate de vincristine
- Médicament: cisplatine
- Médicament: chlorhydrate de doxorubicine
- Procédure: greffe de cellules souches du sang périphérique
- Médicament: melphalan
- Médicament: chlorambucil
- Médicament: dacarbazine
- Médicament: ifosfamide
- Médicament: chlorhydrate de procarbazine
- Médicament: prednisolone
- Médicament: sulfate de vinblastine
- Biologique: sulfate de bléomycine
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Dublin, Irlande, 12
- Our Lady's Hospital For Sick Children
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England
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Birmingham, England, Royaume-Uni, B4 6NH
- Birmingham Children's Hospital
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Bristol, England, Royaume-Uni, BS2 8BJ
- Bristol Royal Hospital for Children
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Cambridge, England, Royaume-Uni, CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
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Leeds, England, Royaume-Uni, LS9 7TF
- Leeds Cancer Centre at St. James's University Hospital
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Leicester, England, Royaume-Uni, LE1 5WW
- Leicester Royal Infirmary
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Liverpool, England, Royaume-Uni, L12 2AP
- Royal Liverpool Children's Hospital, Alder Hey
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London, England, Royaume-Uni, WC1N 3JH
- Great Ormond Street Hospital for Children NHS Trust
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London, England, Royaume-Uni, EC1A 7BE
- Saint Bartholomew's Hospital
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London, England, Royaume-Uni, WIT 3AA
- Meyerstein Institute of Oncology at University College of London Hospitals
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Manchester, England, Royaume-Uni, M27 4HA
- Central Manchester and Manchester Children's University Hospitals NHS Trust
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Newcastle-Upon-Tyne, England, Royaume-Uni, NE7 7DN
- Newcastle Upon Tyne Hospitals NHS Trust
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Nottingham, England, Royaume-Uni, NG7 2UH
- Queen's Medical Centre
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Oxford, England, Royaume-Uni, 0X3 9DU
- Oxford Radcliffe Hospital
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Sheffield, England, Royaume-Uni, S10 2TH
- Children's Hospital - Sheffield
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Southampton, England, Royaume-Uni, SO16 6YD
- Southampton General Hospital
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Sutton, England, Royaume-Uni, SM2 5PT
- Royal Marsden NHS Foundation Trust - Surrey
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Northern Ireland
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Belfast, Northern Ireland, Royaume-Uni, BT12 6BE
- Royal Belfast Hospital for Sick Children
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Scotland
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Aberdeen, Scotland, Royaume-Uni, AB25 2ZN
- Aberdeen Royal Infirmary
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Edinburgh, Scotland, Royaume-Uni, EH9 1LF
- Royal Hospital for Sick Children
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Glasgow, Scotland, Royaume-Uni, G3 8SJ
- Royal Hospital for Sick Children
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Martin Hewitt, MD, BSc, FRCP, FRCPCH, Queen's Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Maladies lymphatiques
- Troubles immunoprolifératifs
- Lymphome
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Antibiotiques, Antinéoplasiques
- Prednisolone
- Étoposide
- Ifosfamide
- Melphalan
- Doxorubicine
- Doxorubicine liposomale
- Vincristine
- Dacarbazine
- Bléomycine
- Vinblastine
- Procarbazine
- Chlorambucil
Autres numéros d'identification d'étude
- CCLG-HD-2000-02
- CDR0000068901 (Identificateur de registre: PDQ (Physician Data Query))
- EU-20108
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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