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

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: 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)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Mount Vernon Cancer Centre at Mount Vernon Hospital

Official(s) and/or principal investigator(s):
Peter J. Hoskin, MD, Study Chair, Affiliation: Mount Vernon Cancer Centre at Mount Vernon Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Primary Purpose: Treatment

Primary outcome: Relapse-free survival

Secondary outcome:

Overall survival

Toxicity

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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): 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

Locations and Contacts

Basildon University Hospital, Basildon, England SS16 5NL, United Kingdom

Royal United Hospital, Bath, England BA1 3NG, United Kingdom

Kent and Canterbury Hospital, Canterbury, England CT1 3NG, United Kingdom

Saint Richards Hospital, Chichester, England P019 4SE, United Kingdom

Walsgrave Hospital, Coventry, England CV2 2DX, United Kingdom

Doncaster Royal Infirmary, Doncaster, England DN2 5LT, United Kingdom

Russells Hall Hospital, Dudley, England DY1 2HQ, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England EX2 5DW, United Kingdom

Hemel Hempstead General, Hemel Hempstead, England HP2 4AD, United Kingdom

Hull Royal Infirmary, Hull, England HU3 2KZ, United Kingdom

King George Hospital, Ilford, Essex, England IG3 8YB, United Kingdom

Lincoln County Hospital, Lincoln, England LN2 5QY, United Kingdom

Aintree University Hospital, Liverpool, England L9 7AL, United Kingdom

Royal Liverpool University Hospital, Liverpool, England L7 8XP, United Kingdom

Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom

St. George's Hospital, London, England SW17 ORE, United Kingdom

University College Hospital - London, London, England WC1E 6AU, United Kingdom

James Paget Hospital, Norfolk, England NR31 6LA, United Kingdom

Mount Vernon Cancer Centre at Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom

Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom

Derriford Hospital, Plymouth, England PL6 8DH, United Kingdom

Portsmouth Oncology Centre at Saint Mary's Hospital, Portsmouth Hants, England PO3 6AD, United Kingdom

Oldchurch Hospital, Romford, England RM7 OBE, United Kingdom

Cancer Research Centre at Weston Park Hospital, Sheffield, England S1O 2SJ, United Kingdom

Southampton General Hospital, Southampton, England SO16 6YD, United Kingdom

Staffordshire General Hospital, Stafford, England ST16 3SA, United Kingdom

Royal Marsden - Surrey, Sutton, England SM2 5PT, United Kingdom

Torbay Hospital, Torquay, England TQ2 7AA, United Kingdom

City Hospital - Birmingham, West Bromwich, England B71 4HJ, United Kingdom

New Cross Hospital, Wolverhampton, England WV10 0QP, United Kingdom

Worthing Hospital, Worthing, England BN11 2DH, United Kingdom

Cancer Care Centre at York Hospital, York, England Y031 8HE, United Kingdom

Craigavon Area Hospital, Craigavon, Northern Ireland BT63 5QQ, United Kingdom

Monklands General Hospital, Airdrie, Scotland ML6 0JF, United Kingdom

Pinderfields General Hospital, Wakefield, Scotland WF1 4DG, United Kingdom

Velindre Cancer Center at Velindre Hospital, Cardiff, Wales CF14 2TL, United Kingdom

South West Wales Cancer Institute, Swansea, Wales SA2 8QA, United Kingdom

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2001
Last updated: September 19, 2013

Page last updated: August 23, 2015

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