Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease

NCT ID: NCT00002714

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-04-30
• Study Completion Date: 2001-09-30

Brief Summary

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.

Detailed Description

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.

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

bleomycin sulfate

Intervention Type: BIOLOGICAL

Stanford V regimen

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

mechlorethamine hydrochloride

Intervention Type: DRUG

prednisone

Intervention Type: DRUG

vinblastine sulfate

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

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

PRIOR CONCURRENT THERAPY: No prior therapy for Hodgkin's disease No other concurrent antineoplastic therapy No other concurrent investigational drugs

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Principal Investigators

Sandra J. Horning, MD

Role: STUDY_CHAIR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

CDR0000064550

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-H96-0805

Identifier Type: -

Identifier Source: secondary_id

SUMC-G4

Identifier Type: -

Identifier Source: org_study_id