Thalidomide in Treating Patients With Asymptomatic, Indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Thalidomide in Indolent Non-Hodgkin's Lymphoma: A Feasibility Study

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed indolent lymphoma or leukemia of one of the following subtypes: Chronic lymphocytic leukemia Follicular center lymphoma (grade I or II) Lymphoplasmacytic lymphoma Marginal zone lymphoma (nodal, extranodal, or splenic) Small lymphocytic lymphoma Waldenstrom's macroglobulinemia Any stage of disease allowed No hairy cell leukemia No T-cell lymphomas No prior treatment for lymphoma/leukemia Considered appropriate for expectant management Must not require cytotoxic therapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Hemoglobin greater than 10.0 g/dL Platelet count greater than 75,000/mm^3 Hepatic Bilirubin no greater than 2 times normal AST and ALT no greater than 2 times normal Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No uncontrolled congestive heart failure No New York Heart Association class III or IV heart disease No unstable coronary artery disease No myocardial infarction in the past 6 months No serious or uncontrolled arrhythmias No history of thromboembolic disease Pulmonary No asthma or chronic obstructive pulmonary disease requiring the use of home oxygen or frequent oral steroids (prednisone greater than 20 mg per day for 5 days within the past 3 months) Other HIV negative Not pregnant or nursing Negative pregnancy test Not planning to become pregnant in the next 2 years Fertile female patients must use 1 highly effective method and 1 additional effective method of contraception for 1 month prior to, during, and for 1 month after study participation Male patients must use effective barrier contraception during and for 1 month after study participation Willing and able to participate in the S.T.E.P.S. (System for Thalidomide Education and Prescribing Safety) program No contraindications to meeting the requirements of the S.T.E.P.S. program No other prior malignancy except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix No peripheral neuropathy No poorly controlled diabetes defined by either of the following: Glycosylated hemoglobin greater than 8.0 g/dL Known end organ disease (i.e., nephropathy, retinopathy, or neuropathy) No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage I grade 1 follicular lymphoma, stage III grade 1 follicular lymphoma, stage IV grade 1 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, stage I grade 2 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 2 follicular lymphoma, Waldenström macroglobulinemia, contiguous stage II marginal zone lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, stage I marginal zone lymphoma, stage I small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma