Phase II Study of Theophylline in Chronic Lymphocytic Leukemia
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leukemia
Both
Leukemia
Trial Information
Phase II Study of Theophylline in Chronic Lymphocytic Leukemia
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Della Makower, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Albert Einstein College of Medicine of Yeshiva University
Authority:
United States: Federal Government
Study ID:
CDR0000066953
NCT ID:
NCT00003808
Start Date:
May 1999
Completion Date:
Related Keywords:
- Leukemia
- stage 0 chronic lymphocytic leukemia
- stage I chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- B-cell chronic lymphocytic leukemia
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Name | Location |
|---|---|
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| Kaplan Cancer Center | New York, New York 10016 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Colorado Cancer Research Program, Inc. | Denver, Colorado 80209-5031 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| New England Medical Center Hospital | Boston, Massachusetts 02111 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Vanderbilt Cancer Center | Nashville, Tennessee 37232-6838 |
| CCOP - Scottsdale Oncology Program | Scottsdale, Arizona 85259-5404 |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids, Iowa 52403-1206 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| CCOP - Merit Care Hospital | Fargo, North Dakota 58122 |
| CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
| CCOP - Geisinger Clinical and Medical Center | Danville, Pennsylvania 17822-2001 |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls, South Dakota 57105-1080 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Beckman Research Institute, City of Hope | Los Angeles, California 91010 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Allegheny University Hospitals- Hahnemann | Philadelphia, Pennsylvania 19102-1192 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee, Wisconsin 53295 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| Veterans Affairs Medical Center - New York | New York, New York 10010 |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield, Wisconsin 54449 |
| Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago, Illinois 60611 |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh, Pennsylvania 15240 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis, Minnesota 55417 |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
| Veterans Affairs Medical Center - Cleveland | Cleveland, Ohio 44106 |
| Veterans Affairs Medical Center - Nashville | Nashville, Tennessee 37212 |
| Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
| Veterans Affairs Medical Center - Tampa (Haley) | Tampa, Florida 33612 |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
| Veterans Affairs Medical Center - Gainsville | Gainesville, Florida 32608-1197 |
