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Phase II Study of Theophylline in Asymptomatic Patients With Stage 0, I, or II B-cell Chronic Lymphocytic Leukemia Previously Untreated With Chemotherapy (Summary Last Modified 04/2000)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

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 Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Della Makower, MD, Protocol chair(Contact information may not be current)
Ph: 718-430-2302

North Central Cancer Treatment Group

Rajiv Pruthi, MBBS, Protocol chair
Ph: 507-284-2511
Email: pruthi.rajiv@mayo.edu

Registry Information

Official Title		Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

Trial Start Date		1999-05-27

Registered in ClinicalTrials.gov		NCT00003808

Date Submitted to PDQ		1999-03-04

Information Last Verified		2007-09-21

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.