Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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: This phase II trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.

Further Study Information

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 30-60 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 1-8; 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. 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.

Eligibility Criteria

Inclusion Criteria:DISEASE CHARACTERISTICS:

• Diagnosis of stage I or IIA Hodgkin's lymphoma

• Previously untreated disease

• Eligible subtypes:

1. Nodular sclerosis

2. Mixed cellularity

3. 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:

• No prior biologic therapy

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• No prior endocrine therapy

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent investigational drugs

• No other concurrent antineoplastic therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Stanford Cancer Center

Louis Fehrenbacher

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026208
Information obtained from ClinicalTrials.gov on January 11, 2012

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