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

Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT00079105
Collaborator
(none)
175
Enrollment
54
Locations
2
Arms
83
Duration (Months)
3.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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:
  • Eposin
  • Etopophos
  • Vepesid

    • Drug: mitoxantrone hydrochloride
    Treatment
    Other Names:
  • Novantrone

    • Drug: prednisolone
    Treatment
    Other Names:
  • Flo-Pred
  • Pediapred
  • Orapred

    • Drug: procarbazine hydrochloride
    Treatment
    Other Names:
  • Matulane

    • Drug: vinblastine sulfate
    Treatment
    Other Names:
  • Vincristine

    		•
    No Intervention: Registration

    Registration, without treatment

    Outcome Measures

    Primary Outcome Measures

    1. Disease-free survival by routine imaging [6 month intervals]

    Secondary Outcome Measures

    1. Overall survival by routine imaging [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Newcastle-upon-Tyne Hospitals NHS Trust
    ClinicalTrials.gov Identifier:
    NCT00079105
    Other Study ID Numbers:
    • CDR0000354225
    • UON-SHIELD
    • EU-20346
    First Posted:
    Mar 9, 2004
    Last Update Posted:
    Mar 30, 2017
    Last Verified:
    Mar 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust
    stage I adult Hodgkin lymphoma
    stage II adult Hodgkin lymphoma
    stage III adult Hodgkin lymphoma
    stage IV adult Hodgkin lymphoma
    Additional relevant MeSH terms:
    Lymphoma
    Hodgkin Disease
    Prednisolone
    Cyclophosphamide
    Etoposide
    Vincristine
    Mitoxantrone
    Bleomycin
    Vinblastine
    Procarbazine
    Prednisolone phosphate

    Study Results

    No Results Posted as of Mar 30, 2017