RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have early stage Hodgkin's disease.

Condition	Treatment or Intervention	Phase
stage II adult Hodgkin's disease Quality of Life stage I adult Hodgkin's disease	Drug: bleomycin  Drug: doxorubicin  Drug: etoposide  Drug: mechlorethamine  Drug: prednisone  Drug: vinblastine  Drug: vincristine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the progression-free and overall survival at 5 and 10 years after a short-term Stanford V regimen comprising mechlorethamine, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide followed by modified involved-field radiotherapy in patients with favorable, early-stage Hodgkin's disease. II. Determine whether the early and late toxic effects of treatment can be minimized by avoiding staging laparotomy, limiting cumulative doses of chemotherapeutic drugs, and reducing the dose and volume of radiotherapy in these patients. III. Determine the freedom from second disease progression at 5 and 10 years after treatment and treatment-related toxicity in these patients. IV. Determine the quality of life of patients treated with this regimen.

PROTOCOL OUTLINE: Patients receive the Stanford V regimen comprising mechlorethamine IV on days 1 and 29; doxorubicin IV and vinblastine IV on days 1, 15, 29, and 43; oral prednisone every other day on days 1-36 followed by tapered doses; vincristine IV and bleomycin IV on days 8, 22, 36, and 50; and etoposide IV on days 15, 16, 43, and 44. Beginning 2 weeks after completion of chemotherapy and when blood counts recover, patients undergo modified involved-field radiotherapy 5 days a week for 3-4 weeks. Quality of life is assessed. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 5 years.

Ages Eligible for Study:  16 Years   -   60 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven stage I-IIA Hodgkin's disease
• No lymphocyte predominant disease
• No stage IA high neck presentation (above the top of the larynx)
• No mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on chest x-ray
• No constitutional (B) symptoms at diagnosis
• No more than 1 extranodal site of disease

--Prior/Concurrent Therapy--

• No prior therapy for Hodgkin's disease
• No other concurrent antineoplastic therapy
• No other concurrent investigational drugs

--Patient Characteristics--

• Age: 16 to 60
• Performance status: Not specified
• Hematopoietic: Granulocyte count at least 2,000/mm3; Platelet count at least 150,000/mm3
• Hepatic: Bilirubin no greater than 2.5 mg/dL
• Renal: Creatinine no greater than 2 mg/dL
• Other: No other medical condition that would preclude study therapy HIV negative; No other prior malignancy except basal cell skin cancer; Not pregnant

California
      Stanford University Medical Center, Stanford,  California,  94305-5408,  United States

Study chairs or principal investigators

Sandra J. Horning,  Study Chair,  Stanford University   

Study ID Numbers:  CDR0000064550; SUMC-G4; NCI-H96-0805
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002714
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08