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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079105
• Other study ID #: CDR0000354225
• Secondary ID: UON-SHIELDEU-203
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2004
• Last updated: March 29, 2017
• Start date: January 2004
• Est. completion date: December 2010

Study information

• Verified date: March 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• bleomycin sulfate
Treatment

Drug:
• cyclophosphamide
Treatment
• etoposide
Treatment
• mitoxantrone hydrochloride
Treatment
• prednisolone
Treatment
• procarbazine hydrochloride
Treatment
• vinblastine sulfate
Treatment

Locations

Country	Name	City	State
Germany	Medizinische Universitaetsklinik I at the University of Cologne	Cologne
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Monklands General Hospital	Airdrie	Scotland
United Kingdom	Wansbeck General Hospital	Ashington	England
United Kingdom	Barnet General Hospital	Barnet, Hertfordshire
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Good Hope Hospital	Birmingham	England
United Kingdom	Blackpool Victoria Hospital	Blackpool	England
United Kingdom	Royal Bournemouth Hospital	Bournemouth	England
United Kingdom	Bradford Royal Infirmary	Bradford	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Cumberland Infirmary	Carlisle	England
United Kingdom	Saint Richards Hospital	Chichester	England
United Kingdom	University Hospital of North Durham	Durham	England
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Queen Elizabeth Hospital	Gateshead-Tyne and Wear	England
United Kingdom	Medway Maritime Hospital	Gillingham Kent	England
United Kingdom	Western Infirmary	Glasgow	Scotland
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	Harrogate District Hospital	Harrogate	England
United Kingdom	Hull Royal Infirmary	Hull	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Airedale General Hospital	Keighley	England
United Kingdom	Kettering General Hosptial	Kettering, Northants	England
United Kingdom	Leeds General Infirmary	Leeds	England
United Kingdom	Leicester Royal Infirmary	Leicester	England
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	University College Hospital - London	London	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Manchester Royal Infirmary	Manchester	England
United Kingdom	Trafford General Hospital	Manchester	England
United Kingdom	James Cook University Hospital	Middlesbrough	England
United Kingdom	Northern Centre for Cancer Treatment at Newcastle General Hospital	Newcastle-Upon-Tyne	England
United Kingdom	University of Newcastle-Upon-Tyne Northern Institute for Cancer Research	Newcastle-Upon-Tyne	England
United Kingdom	North Tyneside Hospital	North Shields	England
United Kingdom	Northampton General Hospital	Northampton	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Royal Alexandra Hospital	Paisley	Scotland
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Pembury Hospital	Royal Tunbridge Wells, Kent	England
United Kingdom	Royal Hallamshire Hospital	Sheffield	England
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	South Tyneside District Hospital	South Shields	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Staffordshire General Hospital	Stafford	England
United Kingdom	University Hospital of North Staffordshire	Stoke-On-Trent Staffs	England
United Kingdom	Sunderland Royal Hospital	Sunderland	England
United Kingdom	Royal Cornwall Hospital	Truro, Cornwall	England
United Kingdom	West Cumberland Hospital	Whitehaven	England
United Kingdom	Wishaw General Hospital	Wishaw	Scotland
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival by routine imaging		6 month intervals
Secondary	Overall survival by routine imaging		5 years