RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
stage I adult Hodgkin's lymphoma stage II adult Hodgkin's lymphoma stage III adult Hodgkin's lymphoma stage IV adult Hodgkin's lymphoma	Drug: bleomycin  Drug: cyclophosphamide  Drug: etoposide  Drug: mitoxantrone  Drug: prednisolone  Drug: procarbazine  Drug: vinblastine  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the efficacy and toxicity of vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin in older patients with Hodgkin's lymphoma.
• Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis.

OUTLINE: This is an open-label, multicenter study.

• Chemotherapy: Patients receive vinblastine IV and cyclophosphamide IV on day 1; oral procarbazine and oral prednisolone on days 1-5; oral etoposide on days 15-19; and mitoxantrone IV and bleomycin IV on day 15. Treatment repeats every 28 days, in the absence of disease progression or unacceptable toxicity, for a total of 3 courses in patients with early (stage IA or IIA) disease or 6 courses in patients with advanced (stage IB or IIB-IV) disease.
• Radiotherapy: Patients with early stage disease receive involved-field radiotherapy. Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease. Radiotherapy begins 4 weeks after the completion of chemotherapy. Patients are followed monthly for 3 months, every 3 months for 6 months, and then annually thereafter.

PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 36 months.

Ages Eligible for Study:  60 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed classical Hodgkin's lymphoma
• Previously untreated disease
• No nodular lymphocyte predominant Hodgkin's lymphoma

PATIENT CHARACTERISTICS: Age

• Over 60

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No significant hepatic abnormality that would preclude study participation

Renal

• No significant renal abnormality that would preclude study participation

Cardiovascular

• No significant cardiac abnormality that would preclude study participation

Pulmonary

• No significant pulmonary abnormality that would preclude study participation

Other

• "Non-fragile" status (i.e., mental and physical status must be sufficient to withstand study therapy)
• HIV negative
• No other concurrent neoplasia

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

United Kingdom, England
      Northern Centre for Cancer Treatment at Newcastle General Hospital, Newcastle upon Tyne,  England,  NE4 6BE,  United Kingdom; Recruiting
      Sir. James Spence Institute, Newcastle upon Tyne,  England,  NE1 4LP,  United Kingdom; Recruiting
      University of Newcastle-Upon-Tyne Northern Institute for Cancer Research, Newcastle upon Tyne,  England,  NE2 4HH,  United Kingdom; Recruiting
United Kingdom, Scotland
      Raigmore Hospital, Inverness,  Scotland,  1V2 3UJ,  United Kingdom; Recruiting

Study chairs or principal investigators

Stephen J. Proctor, MD,  Study Chair,  University of Newcastle Upon-Tyne   

Study ID Numbers:  CDR0000354225; UON-SHIELD; EU-20346; NCT00079105
Record last reviewed:  February 2004
Last Updated:  April 5, 2005
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079105
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08