A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years

March 29, 2017 updated by: Newcastle-upon-Tyne Hospitals NHS Trust

A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years; Vinblastine, Cyclophosphamide, Procarbazine, Prednisolone, Etoposide, Mitoxantrone, and Bleomycin in Treating Older Patients With Hodgkin's Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, D-50924
        • Medizinische Universitaetsklinik I at the University of Cologne
  • United Kingdom
      • Barnet, Hertfordshire, United Kingdom, EN5 3DJ
        • Barnet General Hospital
    • England
      • Ashington, England, United Kingdom, NE63 9JJ
        • Wansbeck General Hospital
      • Basingstoke, England, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire NHS Foundation Trust
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Birmingham, England, United Kingdom, B75 7RR
        • Good Hope Hospital
      • Blackpool, England, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bournemouth, England, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bradford, England, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Canterbury, England, United Kingdom, CT1 3NG
        • Kent and Canterbury Hospital
      • Carlisle, England, United Kingdom, CA2 7HY
        • Cumberland Infirmary
      • Chichester, England, United Kingdom, P019 4SE
        • Saint Richards Hospital
      • Durham, England, United Kingdom, DH1 5TW
        • University Hospital of North Durham
      • Gateshead-Tyne and Wear, England, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital
      • Gillingham Kent, England, United Kingdom, ME7 5NY
        • Medway Maritime Hospital
      • Grimsby, England, United Kingdom, DN33 2BA
        • Diana Princess of Wales Hospital
      • Harrogate, England, United Kingdom, HG2 7SX
        • Harrogate District Hospital
      • Hull, England, United Kingdom, HU3 2KZ
        • Hull Royal Infirmary
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Keighley, England, United Kingdom, BD20 6TD
        • Airedale General Hospital
      • Kettering, Northants, England, United Kingdom, NNI6 8UZ
        • Kettering General Hosptial
      • Leeds, England, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, England, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary
      • Liverpool, England, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, England, United Kingdom, NW1 2PG
        • University College Hospital - London
      • Maidstone, England, United Kingdom, ME16 9QQ
        • Maidstone Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Manchester, England, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Manchester, England, United Kingdom, M31 3SL
        • Trafford General Hospital
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
        • Northern Centre for Cancer Treatment at Newcastle General Hospital
      • Newcastle-Upon-Tyne, England, United Kingdom, NE2 4HH
        • University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
      • North Shields, England, United Kingdom, NE29 8NH
        • North Tyneside Hospital
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital
      • Northwood, England, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Dorset Cancer Centre
      • Royal Tunbridge Wells, Kent, England, United Kingdom, TN2 4QJ
        • Pembury Hospital
      • Sheffield, England, United Kingdom, S1O 2JF
        • Royal Hallamshire Hospital
      • Slough, Berkshire, England, United Kingdom, SL2 4HL
        • Wexham Park Hospital
      • South Shields, England, United Kingdom, NE34 0PL
        • South Tyneside District Hospital
      • Southampton, England, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stafford, England, United Kingdom, ST16 3SA
        • Staffordshire General Hospital
      • Stoke-On-Trent Staffs, England, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
      • Sunderland, England, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Truro, Cornwall, England, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital
      • Whitehaven, England, United Kingdom, CA28 8JG
        • West Cumberland Hospital
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Airdrie, Scotland, United Kingdom, ML6 0JF
        • Monklands General Hospital
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre at Western General Hospital
      • Glasgow, Scotland, United Kingdom, G11 6NT
        • Western Infirmary
      • Inverness, Scotland, United Kingdom, 1V2 3UJ
        • Raigmore Hospital
      • Paisley, Scotland, United Kingdom
        • Royal Alexandra Hospital
      • Wishaw, Scotland, United Kingdom, ML2 0DP
        • Wishaw General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

Histologically confirmed classical Hodgkin Lymphoma (HL). No previous treatment for HL. Age ≥ 60. "Non fragile" patient (see Appendix 1) i.e. patient's mental and physical status must be sufficient to withstand the treatment described.

No concomitant neoplasia requiring treatment or known HIV infection. Written informed consent.

Exclusion criteria:

Nodular lymphocyte predominance Hodgkin Lymphoma (NLPHL) Age <60. Patient previously treated for HL. Known HIV infection or concomitant neoplasia. "Fragile patient" (see Appendix 1) or significant abnormality of another system (pulmonary, cardiac, renal, and hepatic) which is a contraindication to full dose chemotherapy.

Unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Biological: bleomycin sulfate
Treatment
Other Names:
  • Blenoxane
Drug: cyclophosphamide
Treatment
Other Names:
  • Cytoxan
Drug: etoposide
Treatment
Other Names:
  • Vepesid
  • Eposin
  • Etopophos
Drug: mitoxantrone hydrochloride
Treatment
Other Names:
  • Novantrone
Drug: prednisolone
Treatment
Other Names:
  • Orapred
  • Flo-Pred
  • Pediapred
Drug: procarbazine hydrochloride
Treatment
Other Names:
  • Matulane
Drug: vinblastine sulfate
Treatment
Other Names:
  • Vincristine
No Intervention: Registration
Registration, without treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival by routine imaging
Time Frame: 6 month intervals
6 month intervals

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival by routine imaging
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Investigators

  • Study Chair: Stephen J. Proctor, MD, University of Newcastle Upon-Tyne
  • Study Director: Helen H. Lucraft, MD, Northern Centre for Cancer Treatment at Newcastle General Hospital
  • Study Director: Katrina M. Wood, MD, Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 8, 2004

First Submitted That Met QC Criteria

March 8, 2004

First Posted (Estimate)

March 9, 2004

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000354225
  • UON-SHIELD (Other Identifier: Sponsor)
  • EU-20346 (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No IPD were shared, nor will be, for this trial.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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