Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of theophylline in treating patients who have in situ, stage I, or stage II chronic lymphocytic leukemia.

Detailed Description
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OBJECTIVES: I. Determine the response rate in asymptomatic patients with stage 0, I, or II B-cell chronic lymphocytic leukemia treated with theophylline. II. Determine the toxicity of this treatment in these patients. OUTLINE: Patients receive oral theophylline daily. Daily treatment continues for a maximum of 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 1 year. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study over approximately 10 months.

Official Title
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Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Drug: theophylline


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven stage 0, I, or II B-cell chronic lymphocytic leukemia Stable disease that would otherwise be observed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 1 year Hematopoietic: Absolute lymphocyte count greater than 5,000/mm3 Mature lymphocytes with less than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts Bone marrow with at least 30% lymphocytes Hepatic: No cirrhosis Renal: Not specified Cardiovascular: No history of unstable cardiac arrhythmia No active congestive heart failure Other: No history of uncontrolled seizure disorder Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent condition that would make life expectancy less than 1 year PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent interferon alfa Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 months since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: theophylline|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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stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia