AzTrials
AzTrials

LeukemiaPhase 2NCT00003808

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

A Phase 2 study testing theophylline in people with Leukemia, run by Eastern Cooperative Oncology Group at 71 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Leukemia
What is being tested?
theophylline
How many people
Not given
Where
71 sitesin 3 countries
Study dates
11 Aug 1999to Sep 2002
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

71 sites in 3 countries.

71 sites in 3 countries

United States68 sites

  • Veterans Affairs Medical Center - Albany

    Albany, New York, 12208

  • CCOP - Ann Arbor Regional

    Ann Arbor, Michigan, 48106

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • New England Medical Center Hospital

    Boston, Massachusetts, 02111

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

    Chicago, Illinois, 60611

  • Veterans Affairs Medical Center - Chicago (Lakeside)

    Chicago, Illinois, 60611

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Veterans Affairs Medical Center - Cleveland

    Cleveland, Ohio, 44106

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Geisinger Clinical and Medical Center

    Danville, Pennsylvania, 17822-2001

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 10309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • CCOP - Merit Care Hospital

    Fargo, North Dakota, 58122

  • Veterans Affairs Medical Center - Gainsville

    Gainesville, Florida, 32608-1197

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5265

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana, 46202

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Beckman Research Institute, City of Hope

    Los Angeles, California, 91010

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • CCOP - Marshfield Medical Research and Education Foundation

    Marshfield, Wisconsin, 54449

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Veterans Affairs Medical Center - Minneapolis

    Minneapolis, Minnesota, 55417

  • Veterans Affairs Medical Center - Nashville

    Nashville, Tennessee, 37212

  • Vanderbilt Cancer Center

    Nashville, Tennessee, 37232-6838

  • Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • MBCCOP - LSU Medical Center

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Veterans Affairs Medical Center - New York

    New York, New York, 10010

  • Kaplan Cancer Center

    New York, New York, 10016

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • Veterans Affairs Medical Center - Palo Alto

    Palo Alto, California, 94304

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Allegheny University Hospitals- Hahnemann

    Philadelphia, Pennsylvania, 19102-1192

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Veterans Affairs Medical Center - Pittsburgh

    Pittsburgh, Pennsylvania, 15240

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • CCOP - Central Illinois

    Springfield, Illinois, 62526

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

  • Veterans Affairs Medical Center - Tampa (Haley)

    Tampa, Florida, 33612

  • Albert Einstein Comprehensive Cancer Center

    The Bronx, New York, 10461

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • CCOP - Christiana Care Health Services

    Wilmington, Delaware, 19899

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Puerto Rico2 sites

  • MBCCOP - San Juan

    San Juan, 00927-5800

  • Veterans Affairs Medical Center - San Juan

    San Juan, 00927-5800

Other trials in Puerto Rico

South Africa1 site

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: Phase II Study of Theophylline in 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.

Read the 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.

Conditions
Leukemia
Being tested
theophylline
Keywords
stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • theophyllineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2004 (estimated)
  2. Study start11 Aug 1999
  3. Primary completionSep 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003808
Sponsor's protocol ID
CDR0000066953
Other IDs
E-4998, NCCTG-988151
Status last verified
Jun 2023
First submitted
1 Nov 1999
Last updated
22 Jun 2023
Results posted
No

Publications

  • 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.

    PubMed 15356646

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing theophylline in people with Leukemia, run by Eastern Cooperative Oncology Group at 71 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Puerto Rico, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003808, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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