Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to determine the effectiveness of thalidomide in treating patients who have asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
|Study Design:||Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study|
|Study Start Date:||October 2002|
|Study Completion Date:||January 2003|
- Determine the feasibility, in terms of toxicity and patient compliance, of thalidomide in patients with asymptomatic, indolent non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
- Determine the event-free and progression-free survival of patients treated with this drug.
- Determine disease response and time to next treatment in patients treated with this drug.
- Determine the quality of life of patients treated with this drug.
OUTLINE: Patients receive oral thalidomide once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, monthly during study, and at the end of the study.
PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052416
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|United States, Vermont|
|Fletcher Allen Health Care - University Health Center Campus|
|Burlington, Vermont, United States, 05401|
|Study Chair:||Robin Joyce, MD||Beth Israel Deaconess Medical Center|