Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | 18 and over | NCI | E-4998 NCCTG-988151, NCT00003808, E4998 |
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.
Entry Criteria
Disease Characteristics:
Histologically proven stage 0, I, or II B-cell chronic lymphocytic leukemia Stable disease that would otherwise be observed
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
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
Expected Enrollment
A total of 35 patients will be accrued for this study over approximately 10 months.
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.Published Results
Wiernik PH, Paietta E, Goloubeva O, et al.: Phase II study of theophylline in chronic lymphocytic leukemia: a study of the Eastern Cooperative Oncology Group (E4998). Leukemia 18 (10): 1605-10, 2004.[PUBMED Abstract]
Trial Lead Organizations
Eastern Cooperative Oncology Group
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| Della Makower, MD, Protocol chair(Contact information may not be current) | |
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North Central Cancer Treatment Group
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| Rajiv Pruthi, MBBS, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Study of Theophylline in Chronic Lymphocytic Leukemia | |
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| Trial Start Date | 1999-05-27 | |
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| Registered in ClinicalTrials.gov | NCT00003808 | |
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| Date Submitted to PDQ | 1999-03-04 | |
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| Information Last Verified | 2007-09-21 | |
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| NCI Grant/Contract Number | CA21115 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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