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Phase II Study of Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Older Patients With Hodgkin's Lymphoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase II | Treatment | Active | Over 60 | UON-SHIELD
EU-20346, NCT00079105 |
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.
Entry Criteria Disease Characteristics:
- Histologically confirmed classical Hodgkin's lymphoma
- Previously untreated disease
- No nodular lymphocyte predominant Hodgkin's lymphoma
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic - No significant hepatic abnormality that would preclude study participation
Renal - No significant renal abnormality that would preclude study participation
Cardiovascular - No significant cardiac abnormality that would preclude study participation
Pulmonary - No significant pulmonary abnormality that would preclude study participation
Other - "Non-fragile" status (i.e., mental and physical status must be sufficient to withstand study therapy)
- HIV negative
- No other concurrent neoplasia
Expected Enrollment 150A total of 150 patients will be accrued for this study within 36 months. Outcomes Primary Outcome(s)Disease-free survival by routine imaging at 6 month intervals
Secondary Outcome(s)Overall survival by routine imaging at 5 years
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
Trial Contact Information
Trial Lead Organizations University of Newcastle-Upon-Tyne Northern Institute for Cancer Research | | | | Stephen Proctor, MD, FRCP, FRCPath, Protocol chair | | | | | Helen Lucraft, MD, Protocol co-chair | | | | | Katrina Wood, MD, Protocol co-chair | | | |
Trial Sites
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| Germany |
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Cologne |
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| | | | Medizinische Universitaetsklinik I at the University of Cologne |
| | | Andreas Josting, MD | |
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| United Kingdom |
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Barnet, Hertfordshire |
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| | | | Barnet General Hospital |
| | | Contact Person | |
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| England |
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Ashington |
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| | | | Wansbeck General Hospital |
| | | Ian Neilly, MD | |
| | Email:
ian.neilly@northumbria-healthcare.nhs.uk |
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Basingstoke |
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| | | Basingstoke and North Hampshire NHS Foundation Trust |
| | | A E Milne, MBBS, F,R,CP | |
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Bath |
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| | | Royal United Hospital |
| | | C. Singer, MD | |
| | Email:
charles.singer@ruh-bath.swest.nhs.uk |
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Birmingham |
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| | | Good Hope Hospital |
| | | Matthew Lumley, MD | |
| | Email:
matthew.lumley@goodhope.nhs.uk |
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Blackpool |
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| | | Blackpool Victoria Hospital |
| | | Marian Macheta | |
| | Email:
dr.macheta@bfuhospitals.nhs.uk |
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Bournemouth |
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| | | Royal Bournemouth Hospital NHS Trust |
| | | Sally Killick | |
| | Email:
sally.killick@rbch.nhs.uk |
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Bradford |
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| | | Bradford Royal Infirmary |
| | | Lisa Newton, MD | |
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Canterbury |
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| | | Kent and Canterbury Hospital |
| | | Christopher Pocock | |
| | Email:
christopher.pocock@ekht.nhs.uk |
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Carlisle |
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| | | Cumberland Infirmary |
| | | Hugh O'Brien, MD | |
| | Email:
hugh.o'brien@ncumbria.acute.nhs.uk |
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Chichester |
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| | | Saint Richards Hospital |
| | | P.C. Bevan | |
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Durham |
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| | | University Hospital of North Durham |
| | | Fiona Keenan, MD | |
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Gateshead-Tyne and Wear |
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| | | Queen Elizabeth Hospital |
| | | G. P. Summerfield, DM, FRCP, FRCPath | |
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Gillingham Kent |
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| | | Medway Maritime Hospital |
| | | Vivienne Andrews, MD | |
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Grimsby |
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| | | Diana Princess of Wales Hospital |
| | | Hannah Ciepluch, MD | |
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Harrogate |
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| | | Harrogate District Hospital |
| | | A. Geraldine Bynoe, MD | |
| | Email:
geraldine.bynoe@hhc-tr.northy.hs.uk |
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Hull |
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| | | Hull Royal Infirmary |
| | | Russell Patmore, MD | |
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Ipswich |
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| | | Ipswich Hospital |
| | | Nicholas Dodd, MD, FRCP, FRCPath | |
| | Email:
nicholas.dodd@ipswichhospital.nhs.uk |
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Keighley |
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| | | Airedale General Hospital |
| | | Ann Cuthbert | |
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Kettering, Northants |
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| | | Kettering General Hosptial |
| | | M. Lyttelton, MD | |
| | Email:
matthew.lyttelton@kgh.nhs.uk |
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Leeds |
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| | | Leeds General Infirmary |
| | | Roderick Johnson, MD | |
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Leicester |
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| | | Leicester Royal Infirmary |
| | | M. J. Dyer, MD | |
| | Email:
mjsd1@le.ac.uk |
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Liverpool |
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| | | Royal Liverpool University Hospital |
| | | Andrew Pettitt, MA, MD, MRCP, PhD, MRCPath | |
| | Email:
a.r.pettitt@liverpool.ac.uk |
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London |
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| | | University College Hospital - London |
| | | Kirit Ardeshna | |
| | Email:
kirit.ardeshna@uclh.nhs.uk |
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Maidstone |
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| | | Maidstone Hospital |
| | | Don Gillett, FRCP, FRCPath | | Ph: | 44-189-282-3535 ext. 3278 | | |
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| | Email:
don.gillett@nhs.net |
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Manchester |
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| | | Christie Hospital |
| | | John Radford, MD | |
| | | Manchester Royal Infirmary |
| | | Kate Ryan, MD | |
| | | Trafford General Hospital |
| | | P. A. Carrington, MD | |
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Middlesbrough |
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| | | James Cook University Hospital |
| | | Raymond Dang, MD | |
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Newcastle-Upon-Tyne |
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| | | Northern Centre for Cancer Treatment at Newcastle General Hospital |
| | | Helen Lucraft, MD | |
| | Email:
helen.lucraft@nuth.nhs.uk |
| | | University of Newcastle-Upon-Tyne Northern Institute for Cancer Research |
| | | Stephen Proctor, MD, FRCP, FRCPath | |
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North Shields |
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| | | North Tyneside Hospital |
| | | Christopher Tiplady, MD | |
| | Email:
chris.tiplady@nhct.nhs.uk |
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Northampton |
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| | | Northampton General Hospital NHS Trust |
| | | Angela Bowen, MD | |
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Northwood |
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| | | Mount Vernon Cancer Centre at Mount Vernon Hospital |
| | | Peter Hoskin, MD | |
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Poole Dorset |
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| | | Dorset Cancer Centre |
| | | Fergus Jack, MD | |
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Royal Tunbridge Wells, Kent |
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| | | Pembury Hospital |
| | | Don Gillett, FRCP, FRCPath | | Ph: | 44-1892-823-535 ext. 3257 | | |
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Sheffield |
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| | | Royal Hallamshire Hospital |
| | | Josh Wright | |
| | Email:
josh.wright@sth.nhs.uk |
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Slough, Berkshire |
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| | | Wexham Park Hospital |
| | | Simon Moule, MD | |
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South Shields |
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| | | South Tyneside District Hospital |
| | | Mike Galloway, MD | |
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Southampton |
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| | | Southampton General Hospital |
| | | Peter Johnson, MD | |
| | Email:
johnsonp@soton.ac.uk |
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Stafford |
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| | | Staffordshire General Hospital |
| | | Paul Revell, MD | |
| | Email:
jayne.anslow@msgh-tr.wmids.nhs.uk |
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Stoke-On-Trent Staffs |
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| | | University Hospital of North Staffordshire |
| | | R. Chasty | |
| | Email:
richard.chasty@uhns.nhs.uk |
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Sunderland |
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| | | Sunderland Royal Hospital |
| | | Mike Galloway, MD | |
| | Email:
mike.galloway@chs.northy.nhs.uk |
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Truro, Cornwall |
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| | | Royal Cornwall Hospital |
| | | Anton Kruger | |
| | Email:
anton.kruger@rcht.cornwall.nhs.uk |
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Whitehaven |
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| | | West Cumberland Hospital |
| | | Nick West, MD | |
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York |
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| | | Cancer Care Centre at York Hospital |
| | | M. Howard, MD | |
| | Email:
martin.r.Howard@york.nhs.uk |
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| Scotland |
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Aberdeen |
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| | | | Aberdeen Royal Infirmary |
| | | Dominic Culligan, MD | |
| | Email:
dominic.culligan@arh.grampian.scot.nhs.uk |
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Airdrie |
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| | | Monklands General Hospital |
| | | Alaeddin Raafat, MD | |
| | Email:
alaeddin.raafat@lanarkshire.scot.nhs.uk |
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Edinburgh |
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| | | Edinburgh Cancer Centre at Western General Hospital |
| | | John Davies | |
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Glasgow |
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| | | Western Infirmary |
| | | Pamela Mckay, MD | |
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Inverness |
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| | | Raigmore Hospital |
| | | W. Murray | |
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Paisley |
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| | | Royal Alexandra Hospital |
| | | Pamela Mckay, MD | |
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Wishaw |
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| | | Wishaw General Hospital |
| | | Alaeddin Raafat, MD | |
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| Registry Information | | | Official Title | | A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years | | | Trial Start Date | | 2004-01-01 | | | Trial Completion Date | | 2009-09-01 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00079105 | | | Date Submitted to PDQ | | 2004-01-20 | | | Information Last Verified | | 2009-06-30 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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