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A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE


Phase 2
16 Years
60 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A PHASE II TRIAL OF EIGHT-WEEK STANFORD V CHEMOTHERAPY PLUS MODIFIED INVOLVED FIELD RADIOTHERAPY IN FAVORABLE, LIMITED STAGE HODGKIN'S DISEASE


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Sandra J. Horning, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Federal Government

Study ID:

SUMC-G4

NCT ID:

NCT00002714

Start Date:

April 1995

Completion Date:

September 2001

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Stanford University Medical CenterStanford, California  94305-5408