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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bleomycin sulfate
Stanford V regimen
doxorubicin hydrochloride
etoposide
mechlorethamine hydrochloride
prednisone
vinblastine sulfate
vincristine sulfate
radiation therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 14, 2013
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002714
Brief Title
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Early-Stage Hodgkin's Disease
Official Title
A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
September 2001
Overall Recruitment Status
Completed
Study Start Date
April 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
Stanford V regimen
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
mechlorethamine hydrochloride
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra J. Horning, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States

12. IPD Sharing Statement

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

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