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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002714
First received: November 1, 1999
Last updated: May 14, 2013
Last verified: September 2001
  Purpose

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 Intervention Phase
Lymphoma
Biological: bleomycin sulfate
Drug: Stanford V regimen
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: mechlorethamine hydrochloride
Drug: prednisone
Drug: vinblastine sulfate
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 1995
Study Completion Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002714

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Sponsors and Collaborators
Stanford University
Investigators
Study Chair: Sandra J. Horning, MD Stanford University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002714     History of Changes
Other Study ID Numbers: SUMC-G4, CDR0000064550, NCI-H96-0805
Study First Received: November 1, 1999
Last Updated: May 14, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Mechlorethamine
Etoposide
Prednisone
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents
Tubulin Modulators

ClinicalTrials.gov processed this record on July 24, 2014