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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
theophylline
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • Beckman Research Institute, City of Hope
  • Veterans Affairs Medical Center - Palo Alto
  • Stanford University Medical Center
  • CCOP - Colorado Cancer Research Program, Inc.
  • CCOP - Christiana Care Health Services
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Gainsville
  • Sylvester Cancer Center, University of Miami
  • H. Lee Moffitt Cancer Center and Research Institute
  • Veterans Affairs Medical Center - Tampa (Haley)
  • Emory University Hospital - Atlanta
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Veterans Affairs Medical Center - Chicago (Lakeside)
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Central Illinois
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • CCOP - Wichita
  • MBCCOP - LSU Medical Center
  • CCOP - Ochsner
  • Johns Hopkins Oncology Center
  • New England Medical Center Hospital
  • Beth Israel Deaconess Medical Center
  • CCOP - Ann Arbor Regional
  • CCOP - Kalamazoo
  • CCOP - Duluth
  • Veterans Affairs Medical Center - Minneapolis
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - East Orange
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey
  • Veterans Affairs Medical Center - Albany
  • Albert Einstein Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Brooklyn
  • Veterans Affairs Medical Center - New York
  • Kaplan Cancer Center
  • University of Rochester Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • Veterans Affairs Medical Center - Cleveland
  • CCOP - Columbus
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
  • CCOP - Geisinger Clinical and Medical Center
  • Allegheny University Hospitals- Hahnemann
  • University of Pennsylvania Cancer Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute
  • Veterans Affairs Medical Center - Pittsburgh
  • CCOP - MainLine Health
  • CCOP - Sioux Community Cancer Consortium
  • Veterans Affairs Medical Center - Nashville
  • Vanderbilt Cancer Center
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Medical Research and Education Foundation
  • Medical College of Wisconsin
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • MBCCOP - San Juan
  • Veterans Affairs Medical Center - San Juan
  • Pretoria Academic Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), North Central Cancer Treatment Group
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1. Study Identification

Unique Protocol Identification Number
NCT00003808
Brief Title
Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia
Official Title
Phase II Study of Theophylline in Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 11, 1999 (Actual)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), North Central Cancer Treatment Group

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
theophylline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Della Makower, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rajiv K. Pruthi, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Beckman Research Institute, City of Hope
City
Los Angeles
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Veterans Affairs Medical Center - Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209-5031
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Veterans Affairs Medical Center - Gainsville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1197
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Lakeside)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Central Illinois
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
10309-1016
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
MBCCOP - LSU Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Veterans Affairs Medical Center - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Veterans Affairs Medical Center - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Veterans Affairs Medical Center - New York
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Kaplan Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Veterans Affairs Medical Center - Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Geisinger Clinical and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Allegheny University Hospitals- Hahnemann
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Veterans Affairs Medical Center - Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States
Facility Name
Veterans Affairs Medical Center - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
CCOP - Marshfield Medical Research and Education Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
MBCCOP - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
15356646
Citation
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.
Results Reference
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Theophylline in Treating Patients With In Situ, Stage I, or Stage II Chronic Lymphocytic Leukemia

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