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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00041210
• Other study ID #: CDR0000069453
• Secondary ID: BNLI-STANFORDVEU
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 8, 2002
• Last updated: September 19, 2013
• Start date: October 2001

Study information

• Verified date: April 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 850
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• bleomycin sulfate

Drug:
• ABVD regimen

• Stanford V regimen

• dacarbazine

• doxorubicin hydrochloride

• etoposide

• mechlorethamine hydrochloride

• prednisone

• vinblastine sulfate

• vincristine sulfate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Monklands General Hospital	Airdrie	Scotland
United Kingdom	Basildon University Hospital	Basildon	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Kent and Canterbury Hospital	Canterbury	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Saint Richards Hospital	Chichester	England
United Kingdom	Walsgrave Hospital	Coventry	England
United Kingdom	Craigavon Area Hospital	Craigavon	Northern Ireland
United Kingdom	Doncaster Royal Infirmary	Doncaster	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Hemel Hempstead General	Hemel Hempstead	England
United Kingdom	Hull Royal Infirmary	Hull	England
United Kingdom	King George Hospital	Ilford, Essex	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Aintree University Hospital	Liverpool	England
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	University College Hospital - London	London	England
United Kingdom	James Paget Hospital	Norfolk	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Staffordshire General Hospital	Stafford	England
United Kingdom	Royal Marsden - Surrey	Sutton	England
United Kingdom	South West Wales Cancer Institute	Swansea	Wales
United Kingdom	Torbay Hospital	Torquay	England
United Kingdom	Pinderfields General Hospital	Wakefield	Scotland
United Kingdom	City Hospital - Birmingham	West Bromwich	England
United Kingdom	New Cross Hospital	Wolverhampton	England
United Kingdom	Worthing Hospital	Worthing	England
United Kingdom	Cancer Care Centre at York Hospital	York	England

Sponsors (1)

Lead Sponsor	Collaborator
Mount Vernon Cancer Centre at Mount Vernon Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival			No
Secondary	Overall survival			No
Secondary	Toxicity			Yes