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

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ClinicalTrials.gov Identifier: NCT00041210
Recruitment Status : Unknown
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: bleomycin sulfate Drug: ABVD regimen Drug: Stanford V regimen Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: mechlorethamine hydrochloride Drug: prednisone Drug: vinblastine sulfate Drug: vincristine sulfate Radiation: radiation therapy Phase 3

Detailed Description:

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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Protocol for a Randomized Phase III Study of the Stanford V Regimen, Compared With ABVD for the Treatment of Advanced Hodgkin's Disease
Study Start Date : October 2001

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Relapse-free survival

Secondary Outcome Measures :
  1. Overall survival
  2. Toxicity

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041210


Locations
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United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
Saint Richards Hospital
Chichester, England, United Kingdom, P019 4SE
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Doncaster Royal Infirmary
Doncaster, England, United Kingdom, DN2 5LT
Russells Hall Hospital
Dudley, England, United Kingdom, DY1 2HQ
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Hemel Hempstead General
Hemel Hempstead, England, United Kingdom, HP2 4AD
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
King George Hospital
Ilford, Essex, England, United Kingdom, IG3 8YB
Lincoln County Hospital
Lincoln, England, United Kingdom, LN2 5QY
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
St. George's Hospital
London, England, United Kingdom, SW17 ORE
University College Hospital - London
London, England, United Kingdom, WC1E 6AU
James Paget Hospital
Norfolk, England, United Kingdom, NR31 6LA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom, PO3 6AD
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA
City Hospital - Birmingham
West Bromwich, England, United Kingdom, B71 4HJ
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Worthing Hospital
Worthing, England, United Kingdom, BN11 2DH
Cancer Care Centre at York Hospital
York, England, United Kingdom, Y031 8HE
Craigavon Area Hospital
Craigavon, Northern Ireland, United Kingdom, BT63 5QQ
Monklands General Hospital
Airdrie, Scotland, United Kingdom, ML6 0JF
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom, WF1 4DG
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
South West Wales Cancer Institute
Swansea, Wales, United Kingdom, SA2 8QA
Sponsors and Collaborators
Mount Vernon Cancer Centre at Mount Vernon Hospital
Investigators
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Study Chair: Peter J. Hoskin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
More Information
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ClinicalTrials.gov Identifier: NCT00041210     History of Changes
Other Study ID Numbers: CDR0000069453
BNLI-STANFORDV
EU-20206
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: April 2009
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Doxorubicin
Liposomal doxorubicin
Bleomycin
Etoposide
Vincristine
Vinblastine
Mechlorethamine
 Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents