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

Condition(s) targeted: Leukemia

Intervention: theophylline (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Della Makower, MD, Study Chair, Affiliation: Albert Einstein College of Medicine of Yeshiva University
Rajiv K. Pruthi, MBBS, Study Chair, Affiliation: Mayo Clinic

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.

Official title: Phase II Study of Theophylline in Chronic Lymphocytic Leukemia

Study design: Treatment

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

MBCCOP - San Juan, San Juan 00927-5800, Puerto Rico

Veterans Affairs Medical Center - San Juan, San Juan 00927-5800, Puerto Rico

Pretoria Academic Hospital, Pretoria 0001, South Africa

CCOP - Scottsdale Oncology Program, Scottsdale, Arizona 85259-5404, United States

Beckman Research Institute, City of Hope, Los Angeles, California 91010, United States

Stanford University Medical Center, Stanford, California 94305-5408, United States

Veterans Affairs Medical Center - Palo Alto, Palo Alto, California 94304, United States

CCOP - Colorado Cancer Research Program, Inc., Denver, Colorado 80209-5031, United States

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States

Sylvester Cancer Center, University of Miami, Miami, Florida 33136, United States

Veterans Affairs Medical Center - Gainsville, Gainesville, Florida 32608-1197, United States

Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida 33612, United States

Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States

Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia 30033, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Central Illinois, Springfield, Illinois 62526, United States

CCOP - Evanston, Evanston, Illinois 60201, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61602, United States

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois 60611, United States

Veterans Affairs Medical Center - Chicago (Lakeside), Chicago, Illinois 60611, United States

Indiana University Cancer Center, Indianapolis, Indiana 46202-5265, United States

Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana 46202, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 10309-1016, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Ochsner, New Orleans, Louisiana 70121, United States

MBCCOP - LSU Medical Center, New Orleans, Louisiana 70112, United States

Johns Hopkins Oncology Center, Baltimore, Maryland 21287, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

New England Medical Center Hospital, Boston, Massachusetts 02111, United States

CCOP - Ann Arbor Regional, Ann Arbor, Michigan 48106, United States

CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68131, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey 08901, United States

CCOP - Northern New Jersey, Hackensack, New Jersey 07601, United States

Veterans Affairs Medical Center - East Orange, East Orange, New Jersey 07018-1095, United States

Albert Einstein Comprehensive Cancer Center, Bronx, New York 10461, United States

Kaplan Cancer Center, New York, New York 10016, United States

University of Rochester Cancer Center, Rochester, New York 14642, United States

Veterans Affairs Medical Center - Albany, Albany, New York 12208, United States

Veterans Affairs Medical Center - Brooklyn, Brooklyn, New York 11209, United States

Veterans Affairs Medical Center - New York, New York, New York 10010, United States

CCOP - Merit Care Hospital, Fargo, North Dakota 58122, United States

CCOP - Columbus, Columbus, Ohio 43206, United States

CCOP - Toledo Community Hospital Oncology Program, Toledo, Ohio 43623-3456, United States

Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States

Veterans Affairs Medical Center - Cleveland, Cleveland, Ohio 44106, United States

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma 74136, United States

Allegheny University Hospitals- Hahnemann, Philadelphia, Pennsylvania 19102-1192, United States

CCOP - Geisinger Clinical and Medical Center, Danville, Pennsylvania 17822-2001, United States

CCOP - MainLine Health, Wynnewood, Pennsylvania 19096, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, United States

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania 19107, United States

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania 15240, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57105-1080, United States

Vanderbilt Cancer Center, Nashville, Tennessee 37232-6838, United States

Veterans Affairs Medical Center - Nashville, Nashville, Tennessee 37212, United States

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin 54449, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States

Veterans Affairs Medical Center - Madison, Madison, Wisconsin 53705, United States

Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin 53295, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 1999
Last updated: May 23, 2008