Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

NCT00041210 | Unknown Phase 3

• 3 other identifiers: CDR0000069453BNLI-STANFORDVEU-20206
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 37

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced 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; adult lymphocyte predominant Hodgkin lymphoma; adult lymphocyte depletion Hodgkin lymphoma; adult nodular sclerosis Hodgkin lymphoma; adult mixed cellularity Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival

Secondary Outcomes (2)

• Overall survival

• Toxicity

Interventions

bleomycin sulfate BIOLOGICAL

ABVD regimen DRUG

Stanford V regimen DRUG

dacarbazine DRUG

doxorubicin hydrochloride DRUG

etoposide DRUG

mechlorethamine hydrochloride DRUG

prednisone DRUG

vinblastine sulfate DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma (any sub-type) * Stage IB, IIB, IIIA, IIIB, or IV OR * Stage IA or IIA with locally extensive disease (e.g., bulky mediastinal disease (e.g., greater than 0.33 of the maximum transthoracic diameter on routine chest X-ray or at least 2 extranodal sites of disease)) PATIENT CHARACTERISTICS: Age: * 18 to 60 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Complete blood count normal unless directly due to Hodgkin's lymphoma Hepatic: * Hepatic function normal unless directly due to Hodgkin's lymphoma Renal: * Renal function normal unless directly due to Hodgkin's lymphoma Cardiovascular: * No pre-existing cardiac disease Pulmonary: * No pre-existing pulmonary disease Other: * Not pregnant * Fertile patients must use effective contraception during and for six months after study * HIV negative * No other prior malignancy except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No prior therapy for Hodgkin's lymphoma

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mount Vernon Cancer Centre at Mount Vernon Hospital: lead

Study Sites (37)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Kent and Canterbury Hospital

Canterbury, England, CT1 3NG, United Kingdom

Location

Saint Richards Hospital

Chichester, England, P019 4SE, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, England, DN2 5LT, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Hemel Hempstead General

Hemel Hempstead, England, HP2 4AD, United Kingdom

Location

Hull Royal Infirmary

Hull, England, HU3 2KZ, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

St. George's Hospital

London, England, SW17 ORE, United Kingdom

Location

University College Hospital - London

London, England, WC1E 6AU, United Kingdom

Location

James Paget Hospital

Norfolk, England, NR31 6LA, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

City Hospital - Birmingham

West Bromwich, England, B71 4HJ, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Worthing Hospital

Worthing, England, BN11 2DH, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Craigavon Area Hospital

Craigavon, Northern Ireland, BT63 5QQ, United Kingdom

Location

Monklands General Hospital

Airdrie, Scotland, ML6 0JF, United Kingdom

Location

Pinderfields General Hospital

Wakefield, Scotland, WF1 4DG, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Bleomycin; ABVD protocol; Dacarbazine; Doxorubicin; Etoposide; Mechlorethamine; Prednisone; Vinblastine; Vincristine; Radiotherapy

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; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Therapeutics

Study Officials

• Peter J. Hoskin, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Last Updated: September 20, 2013

Record last verified: 2009-04

Locations

GB (37)