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| ID | Type | Description | Link |
|---|---|---|---|
| E-4998 | |||
| NCCTG-988151 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| North Central Cancer Treatment Group | NETWORK |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| theophylline | Drug |
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
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| Name | Affiliation | Role |
|---|---|---|
| Della Makower, MD | Albert Einstein College of Medicine | Study Chair |
| Rajiv K. Pruthi, MBBS | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Scottsdale Oncology Program | Scottsdale | Arizona | 85259-5404 | United States | ||
| Beckman Research Institute, City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15356646 | Result | Wiernik PH, Paietta E, Goloubeva O, Lee SJ, Makower D, Bennett JM, Wade JL, Ghosh C, Kaminer LS, Pizzolo J, Tallman MS; Eastern Cooperative Oncology Group. Phase II study of theophylline in chronic lymphocytic leukemia: a study of the Eastern Cooperative Oncology Group (E4998). Leukemia. 2004 Oct;18(10):1605-10. doi: 10.1038/sj.leu.2403494. |
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| Los Angeles |
| California |
| 91010 |
| United States |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto | California | 94304 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5408 | 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 D.C. | District of Columbia | 20307-5000 | United States |
| Veterans Affairs Medical Center - Gainsville | Gainesville | Florida | 32608-1197 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | 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 |
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois | 60611 | United States |
| Veterans Affairs Medical Center - Chicago (Lakeside) | Chicago | Illinois | 60611 | United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| CCOP - Central Illinois | Springfield | Illinois | 62526 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | 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 |
| MBCCOP - LSU Medical Center | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21287 | United States |
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | 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 |
| Veterans Affairs Medical Center - Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68131 | United States |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Veterans Affairs Medical Center - East Orange | East Orange | New Jersey | 07018-1095 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | 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 |
| Kaplan Cancer Center | New York | New York | 10016 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | United States |
| Albert Einstein Comprehensive Cancer Center | The Bronx | New York | 10461 | United States |
| CCOP - Merit Care Hospital | Fargo | North Dakota | 58122 | United States |
| Ireland Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
| Veterans Affairs Medical Center - Cleveland | Cleveland | Ohio | 44106 | United States |
| CCOP - Columbus | Columbus | Ohio | 43206 | United States |
| CCOP - Toledo Community Hospital Oncology Program | Toledo | Ohio | 43623-3456 | United States |
| CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Geisinger Clinical and Medical Center | Danville | Pennsylvania | 17822-2001 | United States |
| Allegheny University Hospitals- Hahnemann | Philadelphia | Pennsylvania | 19102-1192 | United States |
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Veterans Affairs Medical Center - Pittsburgh | Pittsburgh | Pennsylvania | 15240 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota | 57105-1080 | United States |
| Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | 37212 | United States |
| Vanderbilt Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Veterans Affairs Medical Center - Madison | Madison | Wisconsin | 53705 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792 | United States |
| CCOP - Marshfield Medical Research and Education Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| 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 |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013806 | Theophylline |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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