Non Hodgkin Lymphoma Clinical Trial

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

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 2 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.

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

76

Study ID:

NCT00026208

Recruitment Status:

Completed

Sponsor:

Stanford University

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There are 2 Locations for this study

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Stanford University School of Medicine
Stanford California, 94305, United States
Kaiser Permanente Medical Center
Vallejo California, 94589, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

76

Study ID:

NCT00026208

Recruitment Status:

Completed

Sponsor:


Stanford University

How clear is this clinincal trial information?

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