Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

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 (RT).

- 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 RT 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.

Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60
minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly
on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and
bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60
minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were
assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the
participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of
chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week
for approximately 3 weeks. Subsequent to amendment, all participants received RT.

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

INCLUSION CRITERIA:

- Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes

- Nodular sclerosis

- Mixed cellularity

- Classical, not otherwise specified

- Age ≥ 18 years and ≤ 70 years

- Granulocytes ≥ 2 x 10e6/µL

- Platelets ≥ 150 x 10e6/µL

- Bilirubin ≤ 2.5 mg/dL

- Serum creatinine ≤ 2 mg/dL

- Patients > 50 years or those with a history of cardiac disease should have an ejection
fraction ≥ 50%

- All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment

- Pathologic material reviewed at Stanford University

- Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the
Hodgkin's Disease Staging Conference

- Written informed consent

EXCLUSION CRITERIA:

- Lymphocytic predominance Hodgkin's disease

- Prior treatment for Hodgkin's disease

- Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter
on a standing posteroanterior chest x-ray

- Any lymph node mass > 10 cm in greatest trans-axial diameter

- Two or more extranodal sites of disease

- Constitutional (B) symptoms present at diagnosis

- Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of
the skin)

- Any medical contraindication to the planned treatment, including:

- Pregnant

- Positive antibody test for the human immunodeficiency virus (HIV)