A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00079105
- Lead Sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment bleomycin sulfate Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Treatment cyclophosphamide Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Treatment etoposide Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Treatment mitoxantrone hydrochloride Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Treatment vinblastine sulfate Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Treatment procarbazine hydrochloride Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate Treatment prednisolone Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
- Primary Outcome Measures
Name Time Method Disease-free survival by routine imaging 6 month intervals
- Secondary Outcome Measures
Name Time Method Overall survival by routine imaging 5 years
Trial Locations
- Locations (54)
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, England, United Kingdom
Saint Richards Hospital
🇬🇧Chichester, England, United Kingdom
University Hospital of North Durham
🇬🇧Durham, England, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, England, United Kingdom
Kettering General Hosptial
🇬🇧Kettering, Northants, England, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, Scotland, United Kingdom
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
Good Hope Hospital
🇬🇧Birmingham, England, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead-Tyne and Wear, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
Medway Maritime Hospital
🇬🇧Gillingham Kent, England, United Kingdom
Harrogate District Hospital
🇬🇧Harrogate, England, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Airedale General Hospital
🇬🇧Keighley, England, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
University College Hospital - London
🇬🇧London, England, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Christie Hospital
🇬🇧Manchester, 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
Royal Hallamshire Hospital
🇬🇧Sheffield, 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
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
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
Monklands General Hospital
🇬🇧Airdrie, Scotland, United Kingdom
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Barnet General Hospital
🇬🇧Barnet, Hertfordshire, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, Scotland, United Kingdom
Trafford General Hospital
🇬🇧Manchester, England, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom