RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus low-dose radiation therapy in treating patients who have stage I or stage IIA Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
stage I adult Hodgkin's lymphoma stage II adult Hodgkin's lymphoma adult nodular sclerosis Hodgkin's lymphoma adult mixed cellularity Hodgkin's lymphoma	Drug: bleomycin  Drug: cyclophosphamide  Drug: doxorubicin  Drug: etoposide  Drug: prednisone  Drug: vinblastine  Drug: vincristine  Procedure: chemotherapy  Procedure: radiation therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with Stanford V-C chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy.
• Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of radiotherapy to moderately bulky sites of disease.
• Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 5-30 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1-8; vincristine IV and bleomycin IV over 30-45 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 30-45 minutes on days 1 and 2 of weeks 3 and 7. Beginning 2-3 weeks after completion of chemotherapy, patients undergo low-dose radiotherapy 5 days a week for approximately 3 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 5 years.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of stage I or IIA Hodgkin's lymphoma
• Previously untreated disease
• Eligible subtypes:
• Nodular sclerosis
• Mixed cellularity
• Classical, not otherwise specified
• No lymphocyte-predominant Hodgkin's lymphoma
• No mediastinal mass that is one-third or more of the maximum intrathoracic diameter on a standing posterior chest x-ray
• No lymph node mass more than 10 cm in greatest transaxial diameter
• No more than 1 extranodal site of disease
• No constitutional (B) symptoms present at diagnosis

PATIENT CHARACTERISTICS: Age:

• 18 to 70

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 2,000/mm^3
• Platelet count at least 150,000/mm^3

Hepatic:

• Bilirubin no greater than 2.5 mg/dL

Renal:

• Creatinine no greater than 2 mg/dL

Cardiovascular:

• Ejection fraction at least 50% for patients over age 50 or with a history of cardiac disease

Other:

• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other prior or concurrent malignancy within the past 5 years except basal cell skin cancer
• No other medical contraindication to study therapy

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No other concurrent investigational drugs
• No other concurrent antineoplastic therapy

California
      Kaiser Permanente Medical Center - Vallejo, Vallejo,  California,  94589,  United States; Recruiting
      Stanford Cancer Center at Stanford University Medical Center, Stanford,  California,  94305,  United States; Recruiting

Study chairs or principal investigators

Sandra J. Horning, MD,  Study Chair,  Stanford University   

Study ID Numbers:  CDR0000069002; SUMC-G5; NCI-V01-1671; NCT00026208
Record last reviewed:  July 2003
Last Updated:  December 6, 2004
Record first received:  November 9, 2001
ClinicalTrials.gov Identifier:  NCT00026208
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08