Clinical trial NCT00079105: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2004-03-09
Enrollment: 175
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease-free survival by routine imaging
timeFrame: 6 month intervals
Secondary outcomes:
measure: Overall survival by routine imaging
timeFrame: 5 years
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Medizinische Universitaetsklinik I at the University of Cologne
city: Ashington
country: United Kingdom
facility: Wansbeck General Hospital
state: England
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire NHS Foundation Trust
state: England
city: Bath
country: United Kingdom
facility: Royal United Hospital
state: England
city: Birmingham
country: United Kingdom
facility: Good Hope Hospital
state: England
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
state: England
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
state: England
city: Bradford
country: United Kingdom
facility: Bradford Royal Infirmary
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Carlisle
country: United Kingdom
facility: Cumberland Infirmary
state: England
city: Chichester
country: United Kingdom
facility: Saint Richards Hospital
state: England
city: Durham
country: United Kingdom
facility: University Hospital of North Durham
state: England
city: Gateshead-Tyne and Wear
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Gillingham Kent
country: United Kingdom
facility: Medway Maritime Hospital
state: England
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hospital
state: England
city: Harrogate
country: United Kingdom
facility: Harrogate District Hospital
state: England
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: England
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
state: England
city: Keighley
country: United Kingdom
facility: Airedale General Hospital
state: England
city: Kettering, Northants
country: United Kingdom
facility: Kettering General Hosptial
state: England
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
state: England
city: London
country: United Kingdom
facility: University College Hospital - London
state: England
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: England
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
state: England
city: Manchester
country: United Kingdom
facility: Christie Hospital
state: England
city: Manchester
country: United Kingdom
facility: Trafford General Hospital
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
state: England
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment at Newcastle General Hospital
state: England
city: North Shields
country: United Kingdom
facility: North Tyneside Hospital
state: England
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
state: England
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
city: Poole Dorset
country: United Kingdom
facility: Dorset Cancer Centre
state: England
city: Royal Tunbridge Wells, Kent
country: United Kingdom
facility: Pembury Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: England
city: Slough, Berkshire
country: United Kingdom
facility: Wexham Park Hospital
state: England
city: South Shields
country: United Kingdom
facility: South Tyneside District Hospital
state: England
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: England
city: Stafford
country: United Kingdom
facility: Staffordshire General Hospital
state: England
city: Stoke-On-Trent Staffs
country: United Kingdom
facility: University Hospital of North Staffordshire
state: England
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
state: England
city: Truro, Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital
state: England
city: Whitehaven
country: United Kingdom
facility: West Cumberland Hospital
state: England
city: York
country: United Kingdom
facility: Cancer Care Centre at York Hospital
state: England
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Airdrie
country: United Kingdom
facility: Monklands General Hospital
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Edinburgh Cancer Centre at Western General Hospital
state: Scotland
city: Glasgow
country: United Kingdom
facility: Western Infirmary
state: Scotland
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Scotland
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
state: Scotland
city: Wishaw
country: United Kingdom
facility: Wishaw General Hospital
state: Scotland
city: Barnet, Hertfordshire
country: United Kingdom
facility: Barnet General Hospital
Study officials:
affiliation: University of Newcastle Upon-Tyne
name: Stephen J. Proctor, MD
role: STUDY_CHAIR
affiliation: Northern Centre for Cancer Treatment at Newcastle General Hospital
name: Helen H. Lucraft, MD
role: STUDY_DIRECTOR
affiliation: Sir James Spence Institute of Child Health at Royal Victoria Infirmary
name: Katrina M. Wood, MD
role: STUDY_DIRECTOR
References: