Phase II trial to study the effectiveness of thalidomide in treating patients who have relapsed or refractory low-grade non-Hodgkin's lymphoma. Thalidomide may stop the growth of non-Hodgkin's lymphoma by stopping blood flow to the tumor
PRIMARY OBJECTIVES: I. To estimate the response rate and time-to-progression (TTP) in previously treated patients with low grade non-Hodgkin's lymphoma treated with thalidomide. II. To evaluate the effect of thalidomide on microvascular density in the bone marrow of patients with low grade cell non-Hodgkin's lymphoma. III. To evaluate the effects of thalidomide on bFGF levels in serum and urine. OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Given orally
Correlative studies
Cancer and Leukemia Group B (CALGB) Research Base
Chicago, Illinois, United States
Response rate defined as complete + partial response
Time frame: Up to 5 years
Time to progression
Estimated using the method of Kaplan and Meier using a two-sided significance level α=0.05.
Time frame: Time of patient registration until documented response, assessed up to 5 years
Mean detectable difference in microvessel density (MVD) in patients treated with thalidomide
The biserial correlation estimate will be used to measure the correlation between MVD and tenascin levels pre and post chemotherapy.
Time frame: Up to 6 months
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