Lymphoma Clinical Trial
Official title:
Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine,
work in different ways to stop cancer cells from dividing so they stop growing or die.
Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.
OBJECTIVES:
Primary
- Determine the complete response rate in patients with newly diagnosed stage IA, IB,
IIA, or IIB non-bulky Hodgkin's lymphoma treated with doxorubicin, vinblastine, and
gemcitabine.
Secondary
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful
in predicting clinical relapse and determining the presence of residual disease in
these patients after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and
gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6
courses in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT
scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with
a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is
performed 3 months later if biopsy is negative or biopsy is unable to be performed.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months
for 2 years, and then annually for 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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