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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bleomycin sulfate
cyclophosphamide
etoposide
mitoxantrone hydrochloride
prednisolone
procarbazine hydrochloride
vinblastine sulfate
Sponsored by
Newcastle-upon-Tyne Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

Eligibility Criteria

60 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Universitaetsklinik I at the University of Cologne
  • Wansbeck General Hospital
  • Basingstoke and North Hampshire NHS Foundation Trust
  • Royal United Hospital
  • Good Hope Hospital
  • Blackpool Victoria Hospital
  • Royal Bournemouth Hospital
  • Bradford Royal Infirmary
  • Kent and Canterbury Hospital
  • Cumberland Infirmary
  • Saint Richards Hospital
  • University Hospital of North Durham
  • Queen Elizabeth Hospital
  • Medway Maritime Hospital
  • Diana Princess of Wales Hospital
  • Harrogate District Hospital
  • Hull Royal Infirmary
  • Ipswich Hospital
  • Airedale General Hospital
  • Kettering General Hosptial
  • Leeds General Infirmary
  • Leicester Royal Infirmary
  • Royal Liverpool University Hospital
  • University College Hospital - London
  • Maidstone Hospital
  • Manchester Royal Infirmary
  • Christie Hospital
  • Trafford General Hospital
  • James Cook University Hospital
  • University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
  • Northern Centre for Cancer Treatment at Newcastle General Hospital
  • North Tyneside Hospital
  • Northampton General Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Dorset Cancer Centre
  • Pembury Hospital
  • Royal Hallamshire Hospital
  • Wexham Park Hospital
  • South Tyneside District Hospital
  • Southampton General Hospital
  • Staffordshire General Hospital
  • University Hospital of North Staffordshire
  • Sunderland Royal Hospital
  • Royal Cornwall Hospital
  • West Cumberland Hospital
  • Cancer Care Centre at York Hospital
  • Aberdeen Royal Infirmary
  • Monklands General Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Western Infirmary
  • Raigmore Hospital
  • Royal Alexandra Hospital
  • Wishaw General Hospital
  • Barnet General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment

Registration

Arm Description

Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate

Registration, without treatment

Outcomes

Primary Outcome Measures

Disease-free survival by routine imaging

Secondary Outcome Measures

Overall survival by routine imaging

Full Information

First Posted
March 8, 2004
Last Updated
March 29, 2017
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00079105
Brief Title
A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
Treatment with VEPEMB - Vinblastine sulfate, Cyclophosphamide, Procarbazine hydrochloride, Prednisolone, Etoposide, Mitoxantrone hydrochloride, and Bleomycin sulfate
Arm Title
Registration
Arm Type
No Intervention
Arm Description
Registration, without treatment
Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Other Intervention Name(s)
Blenoxane
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
Eposin, Etopophos, Vepesid
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
mitoxantrone hydrochloride
Other Intervention Name(s)
Novantrone
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
prednisolone
Other Intervention Name(s)
Flo-Pred, Pediapred, Orapred
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Other Intervention Name(s)
Matulane
Intervention Description
Treatment
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Other Intervention Name(s)
Vincristine
Intervention Description
Treatment
Primary Outcome Measure Information:
Title
Disease-free survival by routine imaging
Time Frame
6 month intervals
Secondary Outcome Measure Information:
Title
Overall survival by routine imaging
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J. Proctor, MD
Organizational Affiliation
University of Newcastle Upon-Tyne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helen H. Lucraft, MD
Organizational Affiliation
Northern Centre for Cancer Treatment at Newcastle General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Katrina M. Wood, MD
Organizational Affiliation
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Official's Role
Study Director
Facility Information:
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Wansbeck General Hospital
City
Ashington
State/Province
England
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Good Hope Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
England
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury
State/Province
England
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
State/Province
England
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
University Hospital of North Durham
City
Durham
State/Province
England
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead-Tyne and Wear
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham Kent
State/Province
England
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Harrogate
State/Province
England
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Airedale General Hospital
City
Keighley
State/Province
England
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Facility Name
Kettering General Hosptial
City
Kettering, Northants
State/Province
England
ZIP/Postal Code
NNI6 8UZ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
State/Province
England
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
University College Hospital - London
City
London
State/Province
England
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
State/Province
England
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Trafford General Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M31 3SL
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE2 4HH
Country
United Kingdom
Facility Name
Northern Centre for Cancer Treatment at Newcastle General Hospital
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Facility Name
North Tyneside Hospital
City
North Shields
State/Province
England
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Pembury Hospital
City
Royal Tunbridge Wells, Kent
State/Province
England
ZIP/Postal Code
TN2 4QJ
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2JF
Country
United Kingdom
Facility Name
Wexham Park Hospital
City
Slough, Berkshire
State/Province
England
ZIP/Postal Code
SL2 4HL
Country
United Kingdom
Facility Name
South Tyneside District Hospital
City
South Shields
State/Province
England
ZIP/Postal Code
NE34 0PL
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
State/Province
England
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-On-Trent Staffs
State/Province
England
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
State/Province
England
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro, Cornwall
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
West Cumberland Hospital
City
Whitehaven
State/Province
England
ZIP/Postal Code
CA28 8JG
Country
United Kingdom
Facility Name
Cancer Care Centre at York Hospital
City
York
State/Province
England
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Monklands General Hospital
City
Airdrie
State/Province
Scotland
ZIP/Postal Code
ML6 0JF
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Western Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
State/Province
Scotland
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
State/Province
Scotland
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
Facility Name
Barnet General Hospital
City
Barnet, Hertfordshire
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD were shared, nor will be, for this trial.

Learn more about this trial

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

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