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Clinical Trial Summary

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


Clinical Trial Description

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00022581
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date July 2001

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