Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkin's Lymphoma
NCT ID: NCT00025064
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
260 participants
INTERVENTIONAL
2000-01-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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bleomycin sulfate
chlorambucil
cisplatin
dacarbazine
doxorubicin hydrochloride
etoposide
ifosfamide
melphalan
prednisolone
procarbazine hydrochloride
vinblastine sulfate
vincristine sulfate
peripheral blood stem cell transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Martin Hewitt, MD, BSc, FRCP, FRCPCH
Role: STUDY_CHAIR
Queen's Medical Center
Locations
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Our Lady's Hospital for Sick Children
Dublin, , Ireland
Birmingham Children's Hospital
Birmingham, England, United Kingdom
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool Children's Hospital, Alder Hey
Liverpool, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Great Ormond Street Hospital for Children NHS Trust
London, England, United Kingdom
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, United Kingdom
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
Newcastle upon Tyne, England, United Kingdom
Queen's Medical Centre
Nottingham, England, United Kingdom
Oxford Radcliffe Hospital
Oxford, England, United Kingdom
Children's Hospital - Sheffield
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Royal Belfast Hospital for Sick Children
Belfast, Northern Ireland, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom
Royal Hospital for Sick Children
Glasgow, Scotland, United Kingdom
Countries
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Other Identifiers
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CDR0000068901
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-20108
Identifier Type: -
Identifier Source: secondary_id
CCLG-HD-2000-02
Identifier Type: -
Identifier Source: org_study_id