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

NCT00079105 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000354225UON-SHIELDEU-20346
• Study Type: interventional
• Target: 175
• Locations: 2 countries
• Sites: 54

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.

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival by routine imaging

  6 month intervals

Secondary Outcomes (1)

• Overall survival by routine imaging

  5 years

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Biological: bleomycin sulfate; Drug: cyclophosphamide; Drug: etoposide; Drug: mitoxantrone hydrochloride; Drug: prednisolone; Drug: procarbazine hydrochloride; Drug: vinblastine sulfate

Registration

NO INTERVENTION

Registration, without treatment

Interventions

bleomycin sulfate BIOLOGICAL

Treatment

Also known as: Blenoxane

Treatment

cyclophosphamide DRUG

Treatment

Also known as: Cytoxan

Treatment

etoposide DRUG

Treatment

Also known as: Eposin, Etopophos, Vepesid

Treatment

mitoxantrone hydrochloride DRUG

Treatment

Also known as: Novantrone

Treatment

prednisolone DRUG

Treatment

Also known as: Flo-Pred, Pediapred, Orapred

Treatment

procarbazine hydrochloride DRUG

Treatment

Also known as: Matulane

Treatment

vinblastine sulfate DRUG

Treatment

Also known as: Vincristine

Treatment

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (54)

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Wansbeck General Hospital

Ashington, England, NE63 9JJ, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Good Hope Hospital

Birmingham, England, B75 7RR, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, England, BH7 7DW, United Kingdom

Location

Bradford Royal Infirmary

Bradford, England, BD9 6RJ, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Saint Richards Hospital

Chichester, England, P019 4SE, United Kingdom

Location

University Hospital of North Durham

Durham, England, DH1 5TW, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead-Tyne and Wear, England, NE9 6SX, United Kingdom

Location

Medway Maritime Hospital

Gillingham Kent, England, ME7 5NY, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

Harrogate District Hospital

Harrogate, England, HG2 7SX, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

Location

Kettering General Hosptial

Kettering, Northants, England, NNI6 8UZ, United Kingdom

Location

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

University College Hospital - London

London, England, NW1 2PG, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Manchester Royal Infirmary

Manchester, England, M13 9WL, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Trafford General Hospital

Manchester, England, M31 3SL, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

University of Newcastle-Upon-Tyne Northern Institute for Cancer Research

Newcastle upon Tyne, England, NE2 4HH, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

North Tyneside Hospital

North Shields, England, NE29 8NH, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Pembury Hospital

Royal Tunbridge Wells, Kent, England, TN2 4QJ, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, England, S1O 2JF, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

South Tyneside District Hospital

South Shields, England, NE34 0PL, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-On-Trent Staffs, England, ST4 6QG, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, England, SR4 7TP, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

West Cumberland Hospital

Whitehaven, England, CA28 8JG, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Monklands General Hospital

Airdrie, Scotland, ML6 0JF, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

Location

Wishaw General Hospital

Wishaw, Scotland, ML2 0DP, United Kingdom

Location

Barnet General Hospital

Barnet, Hertfordshire, EN5 3DJ, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; Cyclophosphamide; Etoposide; etoposide phosphate; Mitoxantrone; Prednisolone; Methylprednisolone; prednisolone phosphate; Procarbazine; Vinblastine; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Anthraquinones; Anthrones; Anthracenes; Quinones; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Stephen J. Proctor, MD

  University of Newcastle Upon-Tyne

  STUDY CHAIR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: January 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 30, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); GB (53)