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OpenTrials
Completed

NCT Number: NCT00003808

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MBCCOP - San Juan, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theophylline

Drug

Sponsors and collaborators

Lead sponsor

Eastern Cooperative Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)
  • North Central Cancer Treatment Group

Registry information

Official study title

Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

Important dates

Study start
1999
Primary completion
2002
First posted
Jul 22, 2004
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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