A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
NCT ID: NCT00079105
Last Updated: 2017-03-30
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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COMPLETED
PHASE2
175 participants
INTERVENTIONAL
2004-01-31
2010-12-31
Brief Summary
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PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
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Detailed Description
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Primary
* Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
* Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.
OUTLINE: This is an open-label, multicenter study.
* Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
* Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy.
Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
bleomycin sulfate
Treatment
cyclophosphamide
Treatment
etoposide
Treatment
mitoxantrone hydrochloride
Treatment
prednisolone
Treatment
procarbazine hydrochloride
Treatment
vinblastine sulfate
Treatment
Registration
Registration, without treatment
No interventions assigned to this group
Interventions
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bleomycin sulfate
Treatment
cyclophosphamide
Treatment
etoposide
Treatment
mitoxantrone hydrochloride
Treatment
prednisolone
Treatment
procarbazine hydrochloride
Treatment
vinblastine sulfate
Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.
Exclusion Criteria
Unable to give informed consent.
60 Years
120 Years
ALL
No
Sponsors
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Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Stephen J. Proctor, MD
Role: STUDY_CHAIR
University of Newcastle Upon-Tyne
Helen H. Lucraft, MD
Role: STUDY_DIRECTOR
Northern Centre for Cancer Treatment at Newcastle General Hospital
Katrina M. Wood, MD
Role: STUDY_DIRECTOR
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Locations
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Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Wansbeck General Hospital
Ashington, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom
Royal United Hospital
Bath, England, United Kingdom
Good Hope Hospital
Birmingham, England, United Kingdom
Blackpool Victoria Hospital
Blackpool, England, United Kingdom
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom
Bradford Royal Infirmary
Bradford, England, United Kingdom
Kent and Canterbury Hospital
Canterbury, England, United Kingdom
Cumberland Infirmary
Carlisle, England, United Kingdom
Saint Richards Hospital
Chichester, England, United Kingdom
University Hospital of North Durham
Durham, England, United Kingdom
Queen Elizabeth Hospital
Gateshead-Tyne and Wear, England, United Kingdom
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom
Harrogate District Hospital
Harrogate, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Airedale General Hospital
Keighley, England, United Kingdom
Kettering General Hosptial
Kettering, Northants, England, United Kingdom
Leeds General Infirmary
Leeds, England, United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
University College Hospital - London
London, England, United Kingdom
Maidstone Hospital
Maidstone, England, United Kingdom
Manchester Royal Infirmary
Manchester, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Trafford General Hospital
Manchester, England, United Kingdom
James Cook University Hospital
Middlesbrough, England, United Kingdom
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
North Tyneside Hospital
North Shields, England, United Kingdom
Northampton General Hospital
Northampton, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom
Dorset Cancer Centre
Poole Dorset, England, United Kingdom
Pembury Hospital
Royal Tunbridge Wells, Kent, England, United Kingdom
Royal Hallamshire Hospital
Sheffield, England, United Kingdom
Wexham Park Hospital
Slough, Berkshire, England, United Kingdom
South Tyneside District Hospital
South Shields, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Staffordshire General Hospital
Stafford, England, United Kingdom
University Hospital of North Staffordshire
Stoke-On-Trent Staffs, England, United Kingdom
Sunderland Royal Hospital
Sunderland, England, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom
West Cumberland Hospital
Whitehaven, England, United Kingdom
Cancer Care Centre at York Hospital
York, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Monklands General Hospital
Airdrie, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Raigmore Hospital
Inverness, Scotland, United Kingdom
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Wishaw General Hospital
Wishaw, Scotland, United Kingdom
Barnet General Hospital
Barnet, Hertfordshire, , United Kingdom
Countries
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Other Identifiers
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UON-SHIELD
Identifier Type: OTHER
Identifier Source: secondary_id
EU-20346
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000354225
Identifier Type: -
Identifier Source: org_study_id
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