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Clinical Trial: Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma
This study is currently recruiting patients.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult Hodgkin's lymphoma | Drug: bleomycin Drug: dacarbazine Drug: doxorubicin Drug: etoposide Drug: mechlorethamine Drug: prednisone Drug: vinblastine Drug: vincristine Procedure: chemotherapy Procedure: radiation therapy | Phase III |
MedlinePlus related topics: Hodgkin's Disease
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Bleomycin, Doxorubicin, Etoposide, Mechlorethamine, Vinblastine, Vincristine, and Prednisone (Stanford V) Versus Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) in Patients With Previously Untreated Advanced Hodgkin's Lymphoma
Further Study Details:
OBJECTIVES:
- Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
- Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses. All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years - 60 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
United Kingdom, England
Aintree University Hospital, Liverpool, England, L9 7AL, United Kingdom; Recruiting
Barrie E. Woodcock, MD 44-0151-529-4655
Basildon University Hospital, Basildon, England, SS16 5NL, United Kingdom; Recruiting
Paul Cervi, MD 44-1268-593-018
Cancer Care Centre at York Hospital, York, England, Y031 8HE, United Kingdom; Recruiting
L. R. Bond, MD 44-1904-725-854
Cancer Research Centre at Weston Park Hospital, Sheffield, England, S1O 2SJ, United Kingdom; Recruiting
B.W. Hancock, MD 44-114-226-5000 ext. 5007 b.w.hancock@sheffield.ac.uk
City Hospital - Birmingham, West Bromwich, England, B71 4HJ, United Kingdom; Recruiting
Penny J. Stableforth, MD 44-121-553-1831
Derriford Hospital, Plymouth, England, PL6 8DH, United Kingdom; Recruiting
Simon Rule, MD 44-1752-517-505
Doncaster Royal Infirmary, Doncaster, England, DN2 5LT, United Kingdom; Recruiting
Paul 44-1302-366-666
Hemel Hempstead General, Hemel Hempstead, England, United Kingdom; Recruiting
J F M Harrison, MD 44-1442-213-141
Hull Royal Infirmary, Hull, England, HU3 2KZ, United Kingdom; Recruiting
R. Patmore, MD 44-014-8232-8541
James Paget Hospital, Norfolk, England, NR31 6LA, United Kingdom; Recruiting
Shalal Sadullah, MD 44-01-493-452-827 shalal.sadullah@jiaget.nhs.uk
Kent and Canterbury Hospital, Canterbury, England, CT2 7NR, United Kingdom; Recruiting
C. Pocock 44-1227-76677
King George Hospital, Ilford, Essex, England, IG3 8YB, United Kingdom; Recruiting
Naim Akhtar, MD 44-208-535-6912 naim.akhtar@whippsx.nhs.uk
Lincoln County Hospital, Lincoln, England, LN2 5QY, United Kingdom; Recruiting
M. Adelman 44-1522-51-2512
Mount Vernon Hospital, Northwood, England, HA6 2RN, United Kingdom; Recruiting
Peter John Hoskin, MD 44-019-2384-4533
New Cross Hospital, Wolverhampton, England, WV10 0QP, United Kingdom; Recruiting
C Brammer, MD 44-1902-307-999
Nottingham City Hospital NHS Trust, Nottingham, England, NG5 1PB, United Kingdom; Recruiting
A. McMillan 44-115-969-1169
Oldchurch Hospital, Romford, England, RM7 OBE, United Kingdom; Recruiting
Alison Brownell, MD 44-0170-345-533
Portsmouth Hospitals NHS Trust, Portsmouth, England, P03 6AD, United Kingdom; Recruiting
Ann O'Callaghan, MD 44-023-92-286-000 an.ocallaghan@porthosp.nhs.uk
Royal Devon and Exeter Hospital, Exeter, England, EX2 5DW, United Kingdom; Recruiting
M. V. Joyner, MD 44-1392-402-928
Royal Liverpool and Broadgreen Hospitals, Liverpool, England, L7 8XP, United Kingdom; Recruiting
A. R. Pettit, MD 44-151-706-4363
Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, SM2 5PT, United Kingdom; Recruiting
David Cunningham, MD 44-208-642-6011 dcunn@ar.ac.uk
Royal United Hospital, Bath, England, BA1 3NG, United Kingdom; Recruiting
C. J.C. Knechtli, MB, ChB, PhD, FRCP, MRCPath 44-1225-824-704
Russells Hall Hospital, Dudley, England, DY1 2HQ, United Kingdom; Recruiting
J. R. Neilson 44-1384-45-6111
Saint Bartholomew's Hospital, London, England, EC1A 7BE, United Kingdom; Recruiting
Thomas Andrew Lister, MD, FRCP, FRCPath 44-20-7601-7462 andrew.lister@cancer.org.uk
Saint Richards Hospital, Chichester, England, P019 4SE, United Kingdom; Recruiting
P.C. Bevan 44-1243-788-122
Southampton General Hospital, Southampton, England, SO16 6YD, United Kingdom; Recruiting
Peter Johnson, MD 44-23-8079-6185 johnsonp@soton.ac.uk
St. George's Hospital, London, England, SW17 ORE, United Kingdom; Recruiting
Ruth Pettengell, MD 44-20-8725-5454 r.petteng@sghms.ac.uk
Staffordshire General Hospital, Stafford, England, ST16 3SA, United Kingdom; Recruiting
Paul Revell, MD 44-1785-257-731 jayne.anslow@msgh-tr.wmids.nhs.uk
Torbay Hospital, Torquay Devon, England, TQ2 7AA, United Kingdom; Recruiting
S.R. Smith, MD 44-1803-65-5237
University College Hospital, London, England, WC1E 6AU, United Kingdom; Recruiting
Antony H. Goldstone, FRCP 44-20-7380-9678 anthony.golstone@uclh.org
Walsgrave Hospital, Coventry, England, CV2 2DX, United Kingdom; Recruiting
B. Harrison 44-24-766-0202
Worthing Hospital, Worthing, England, BN11 2DH, United Kingdom; Recruiting
A. O'Driscolla 44-1903-20-5111
United Kingdom, Northern Ireland
Craigavon Area Hospital, Craigavon, Northern Ireland, BT63 5QQ, United Kingdom; Recruiting
H. Kathryn Boyd, MD 44-28-3833-4444
United Kingdom, Scotland
Monklands General Hospital, Airdrie, Scotland, ML6 0JF, United Kingdom; Recruiting
J Murphy, MD 44-1236-748-748 john.murphy@lanahshire.scot.nhs.uk
Pinderfields Hospital NHS Trust, Wakefield, Scotland, WF1 4DG, United Kingdom; Recruiting
P. Hillmen, MD 44-192-420-1688 peter.hillmen@panp-tr.northy.nhs.uk
United Kingdom, Wales
Singleton Hospital, Swansea, Wales, SA 2 8QA, United Kingdom; Recruiting
A. Benton 44-1792-28-5299 ann.benton@swansea-br.wales.nhs.uk
Velindre Cancer Center at Velinde Hospital, Cardiff, Wales, CF14 2TL, United Kingdom; Recruiting
Philip Savage, MD 02920 312297
Study chairs or principal investigators
Peter John Hoskin, MD, Study Chair, Mount Vernon Hospital
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000069453; BNLI-STANFORDV; EU-20206; NCT00041210
Record last reviewed: January 2004
Last Updated: April 4, 2005
Record first received: July 8, 2002
ClinicalTrials.gov Identifier: NCT00041210
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: January 2004
Last Updated: April 4, 2005
Record first received: July 8, 2002
ClinicalTrials.gov Identifier: NCT00041210
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Mechlorethamine (Drug Digest)
- Mustargen (Drug Digest)
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