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Last Modified: 2/5/2010     First Published: 12/16/2005  
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Study of Adherence to Long-Term Maintenance Mercaptopurine Therapy in Younger Patients With Acute Lymphoblastic Leukemia in First Remission (Closed to Accrual for Caucasian and Hispanic Patients as of 8/14/2009)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Study to Assess Compliance With Long-Term Mercaptopurine Treatment in Young Patients With Acute Lymphoblastic Leukemia in Remission (Closed to Accrual for Caucasian and Hispanic Patients as of 8/14/2009)

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
No phase specifiedTreatmentActive21 and under at diagnosisNCICOG-AALL03N1
NCT00268528

Special Category: NCI Web site featured trial

Objectives

Primary

  1. Determine and compare adherence to maintenance mercaptopurine using the following assessments: serial red cell mercaptopurine metabolites (i.e., 6TGN and methylTIMP), frequency of mercaptopurine dosing using an electronic pill monitoring system (MEMS®), and self-report of adherence to mercaptopurine by questionnaire in a cohort of younger patients with acute lymphoblastic leukemia in first remission who belong to four different ethnic and racial groups (Caucasians, African-Americans, Hispanics, and Asians).
  2. Determine the impact of adherence to mercaptopurine on event-free-survival (EFS) in the entire cohort, after adjusting for known predictors of disease outcome.
  3. Define a critical level of adherence that has a significant impact on EFS for the entire cohort.
  4. Describe prevalence of adherence to mercaptopurine by ethnicity.
  5. Describe behavioral and sociodemographic predictors of adherence.
  6. Describe the pill-taking practices in this cohort.
  7. Evaluate the impact of adherence on ethnic/racial difference in EFS.

Secondary

  1. Assess the concordance among 6TGN and methylTIMP levels, electronic pill monitoring, and self-reported adherence in the ethnic/racial groups.

Entry Criteria

Disease Characteristics:

  • Diagnosis of acute lymphoblastic leukemia (ALL) at ≤ 21 years of age
    • Disease in first remission

  • Receiving self- or parent/caregiver-administered oral antimetabolite chemotherapy during the maintenance phase of therapy
    • Has completed at least two courses* of maintenance chemotherapy, and is scheduled to receive at least two more planned courses of maintenance chemotherapy

       [Note: *A course is defined as 12 weeks/84 days of maintenance chemotherapy.]

      • Treatment plan must include oral mercaptopurine (6-MP) at 75 mg/m2/day and oral methotrexate at 20 mg/m2/week during the maintenance phase
        • Dose modification of 6-MP or methotrexate based on laboratory or clinical parameters is acceptable

Prior/Concurrent Therapy:

  • See Disease Characteristics
  • Concurrent enrollment on another therapeutic study for ALL allowed

Patient Characteristics:

  • Belongs to one of the four following ethnic/racial categories: African-American, Asian, Caucasian*, or Hispanic*

     [Note: Closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.]

Expected Enrollment

720

A total of 720 patients will be accrued for this study.

Outline

This is a multicenter study.

Patients* receive an electronic pill monitoring system comprising an empty MEMS® medication bottle with TrackCap™ child resistant (CR). The mercaptopurine prescription is filled using this system. Beginning on day 1 of the third or later course of maintenance therapy, patients take all doses of mercaptopurine from the MEMS® medication bottle with TrackCap™ CR for at least 6 months. The MEMS® TrackCap™ CR is mailed to the study center at the end of study. Patients also receive oral methotrexate as indicated by their individual chemotherapy regimen.

 [Note: *Study closed to accrual for Caucasian and Hispanic patients as of 8/14/2009.]

Blood samples are collected on days 1, 29, 57, 85, 113, 141, and 169. Patient or caregiver completes demographic questionnaire on day 29. Patient and/or caregiver completes a self-reported adherence questionnaire on days 29, 57, 113, and 141.

After completion of study treatment, patients are followed periodically.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Smita Bhatia, MD, Protocol chair
Ph: 800-826-4673
Email: becomingapatient@coh.org
Mary Relling, PharmD, Protocol co-chair
Ph: 901-495-2348
Email: mary.relling@stjude.org

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 Clinical Trials Office - UAB Comprehensive Cancer Center
Ph: 205-934-0309
Arkansas
  Little Rock
 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
 Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Ph: 501-686-8274
California
  Downey
 Southern California Permanente Medical Group
 Robert Cooper
Ph: 323-783-5307
  Duarte
 City of Hope Comprehensive Cancer Center
 Clinical Trials Office - City of Hope Comprehensive Cancer Center
Ph: 800-826-4673
 Email: becomingapatient@coh.org
  Loma Linda
 Loma Linda University Cancer Institute at Loma Linda University Medical Center
 Clinical Trials Office - Loma Linda University Cancer Institute
Ph: 909-558-3375
  Long Beach
 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
 Jerry Finklestein
Ph: 562-492-1062
  Los Angeles
 Childrens Hospital Los Angeles
 Leo Mascarenhas
Ph: 323-361-2529
 Jonsson Comprehensive Cancer Center at UCLA
 Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA
Ph: 888-798-0719
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Carole Hurvitz
Ph: 310-423-4423
  Madera
 Children's Hospital Central California
 Vonda Crouse
Ph: 559-353-5480
  Oakland
 Children's Hospital and Research Center Oakland
 Clinical Trial Office - Children's Hospital and Research Center Oakland
Ph: 510-450-7600
  Sacramento
 University of California Davis Cancer Center
 Clinical Trials Office - University of California Davis Cancer Center
Ph: 916-734-3089
  San Diego
 Rady Children's Hospital - San Diego
 Clinical Trials Office - Rady Children's Hospital - San Diego
Ph: 858-966-5934
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  Stanford
 Stanford Cancer Center
 Clinical Trials Office - Stanford Cancer Center
Ph: 650-498-7061
 Email: cctoffice@stanford.edu
Colorado
  Aurora
 Children's Hospital Center for Cancer and Blood Disorders
 Kelly Maloney
Ph: 720-777-6673
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center
Ph: 800-579-7822
  New Haven
 Yale Cancer Center
 Clinical Trials Office - Yale Cancer Center
Ph: 203-785-5702
District of Columbia
  Washington
 Children's National Medical Center
 Clinical Trials Office - Children's National Medical Center
Ph: 202-884-2549
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Clinical Trials Office - Lombardi Comprehensive Cancer Center
Ph: 202-444-0381
Florida
  Fort Myers
 Lee Cancer Care of Lee Memorial Health System
 Clinical Trials Office - Lee Cancer Care of Lee Memorial Health System
Ph: 877-680-0008
  Gainesville
 University of Florida Shands Cancer Center
 Clinical Trials Office - University of Florida Shands Cancer Center
Ph: 888-254-7581
  Hollywood
 Memorial Cancer Institute at Memorial Regional Hospital
 Clinical Trials Office - Memorial Cancer Institute
Ph: 954-985-3443
  Miami
 Baptist-South Miami Regional Cancer Program
 Doured Daghistani
Ph: 305-274-1662
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124
 Email: Sylvester@emergingmed.com
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Clinical Trials Office - Florida Hospital Cancer Institute
Ph: 407-303-5623
 Nemours Children's Clinic - Orlando
 Paul Gordon
Ph: 407-650-7330
  Saint Petersburg
 All Children's Hospital
 Gregory Hale
Ph: 727-767-4176
  Tampa
 St. Joseph's Cancer Institute at St. Joseph's Hospital
 Clinical Trials Office - St. Joseph's Cancer Institute
Ph: 800-882-4123
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Howard Katzenstein
Ph: 404-785-0853
  Augusta
 MBCCOP - Medical College of Georgia Cancer Center
 Colleen McDonough
Ph: 706-721-3626
Illinois
  Chicago
 University of Illinois Cancer Center
 Clinical Trial Office - University of Illinois Cancer Center
Ph: 312-355-3046
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
  Oak Lawn
 Keyser Family Cancer Center at Advocate Hope Children's Hospital
 Sharad Salvi
Ph: 708-684-4094
  Park Ridge
 Advocate Lutheran General Cancer Care Center
 Clinical Trials Office - Advocate Lutheran General Cancer Care Center
Ph: 847-384-3621
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
 St. Vincent Indianapolis Hospital
 Clinical Trials Office - St. Vincent Indianapolis Hospital
Ph: 317-338-2194
Iowa
  Des Moines
 Blank Children's Hospital
 Clinical Trials Office - Blank Children's Hospital
Ph: 515-241-6729
Louisiana
  Alexandria
 Tulane Cancer Center Office of Clinical Research
 Clinical Trials Office - Tulane Cancer Center
Ph: 504-988-6121
Michigan
  Ann Arbor
 C.S. Mott Children's Hospital at University of Michigan Medical Center
 Clinical Trials Office - C.S. Mott Children's Hospital
Ph: 1-800-865-1125
  Flint
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grand Rapids
 Butterworth Hospital at Spectrum Health
 David Dickens
Ph: 616-391-2086
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
Minnesota
  Minneapolis
 Children's Hospitals and Clinics of Minnesota - Minneapolis
 Clinical Trials Office - Children's Hospitals and Clinics of Minnesota
Ph: 612-813-5193
Mississippi
  Jackson
 University of Mississippi Cancer Clinic
 Gail Megason
Ph: 601-984-5220
Missouri
  Columbia
 Ellis Fischel Cancer Center at University of Missouri - Columbia
 Clinical Trial Office - Ellis Fischel Cancer Center
Ph: 573-882-7440
  Kansas City
 Children's Mercy Hospital
 Maxine Hetherington
Ph: 816-234-3265
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Robert Hayashi
Ph: 314-454-4118
Nebraska
  Omaha
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Clinical Trials Office - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Ph: 800-999-5465
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 Jonathan Bernstein
Ph: 702-732-0971
 Jonathan Bernstein
Ph: 702-732-1493
New Hampshire
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Clinical Trials Office - Norris Cotton Cancer Center
Ph: 603-650-7609
 Email: cancerhelp@dartmouth.edu
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Clinical Trials Office - Hackensack University Medical Center Cancer Center
Ph: 201-996-2879
  Morristown
 Overlook Hospital
 Hazem Mahmoud
Ph: 973-971-6720
  Paterson
 St. Joseph's Hospital and Medical Center
 Mary Bonilla
Ph: 973-754-3349
New Mexico
  Albuquerque
 University of New Mexico Cancer Center
 Clinical Trials Office - University of New Mexico Cancer Center
Ph: 505-272-6972
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine
Ph: 718-904-2730
 Email: aecc@aecom.yu.edu
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
  Mineola
 Winthrop University Hospital
 Contact Person
Ph: 516-663-9500
  New York
 Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
 Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
Ph: 212-305-8615
 NYU Cancer Institute at New York University Medical Center
 Elizabeth Raetz
Ph: 212-263-8400
  Syracuse
 SUNY Upstate Medical University Hospital
 Clinical Trials Office - SUNY Upstate Medical University Hospital
Ph: 315-464-5476
  Valhalla
 New York Medical College
 Fevzi Ozkaynak
Ph: 914-493-7997
North Carolina
  Asheville
 Mission Hospitals - Memorial Campus
 Clinical Trials Office - Mission Hospitals - Memorial Campus
Ph: 828-213-4150
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital
Ph: 704-384-5369
  Durham
 Duke Comprehensive Cancer Center
 Clinical Trials Office - Duke Comprehensive Cancer Center
Ph: 888-275-3853
  Winston-Salem
 Wake Forest University Comprehensive Cancer Center
 Clinical Trials Office - Wake Forest University Comprehensive Cancer Center
Ph: 336-713-6771
Ohio
  Akron
 Akron Children's Hospital
 Clinical Trials Office - Akron Children's Hospital
Ph: 330-543-3193
  Dayton
 Children's Medical Center - Dayton
 Emmett Broxson
Ph: 937-641-3111
  Toledo
 Toledo Hospital
 Clinical Trials Office - Toledo Hospital
Ph: 419-824-1842
Oregon
  Portland
 Legacy Emanuel Hospital and Health Center and Children's Hospital
 Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital
Ph: 503-413-8199
Pennsylvania
  Bethlehem
 Lehigh Valley Hospital - Muhlenberg
 Philip Monteleone
Ph: 484-884-3333
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  Philadelphia
 Children's Hospital of Philadelphia
 Richard Aplenc
Ph: 267-426-7252
  Pittsburgh
 Children's Hospital of Pittsburgh
 Clinical Trials Office - Children's Hospital of Pittsburgh
Ph: 412-692-7056
Rhode Island
  Providence
 Rhode Island Hospital Comprehensive Cancer Center
 Clinical Trials Office - Rhode Island Hospital Comprehensive Cancer Center
Ph: 401-444-1488
South Carolina
  Columbia
 Palmetto Health South Carolina Cancer Center
 Clinical Trials Office - Palmetto Health South Carolina Cancer Center
Ph: 803-434-3680
South Dakota
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Clinical Trials Office - Sanford Cancer Center
Ph: 605-328-1367
Tennessee
  Chattanooga
 T.C. Thompson Children's Hospital
 Manoo Bhakta
Ph: 423-778-7289
  Knoxville
 East Tennessee Children's Hospital
 Ray Pais
Ph: 865-541-8266
  Nashville
 Vanderbilt-Ingram Cancer Center
 Clinical Trials Office - Vanderbilt-Ingram Cancer Center
Ph: 800-811-8480
Texas
  Amarillo
 Texas Tech University Health Sciences Center School of Medicine - Amarillo
 Curtis Turner
Ph: 806-354-5434X264
  Austin
 Dell Children's Medical Center of Central Texas
 Clinical Trials Office - Dell Children's Medical Center of Central Texas
Ph: 512-324-8022
  Corpus Christi
 Driscoll Children's Hospital
 Clinical Trials Office - Driscoll Children's Hospital
Ph: 361-694-5311
  Dallas
 Medical City Dallas Hospital
 Carl Lenarsky
Ph: 972-566-6647x4439
 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
 Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Ph: 866-460-4673; 214-648-7097
  Houston
 Baylor University Medical Center - Houston
 Patrick Thompson
Ph: 832-824-4029
  San Antonio
 Methodist Children's Hospital of South Texas
 Michael Grimley
Ph: 210-575-7268
 University of Texas Health Science Center at San Antonio
 Paul Thomas
Ph: 210-704-2187
  Temple
 CCOP - Scott and White Hospital
 Arlynn Mulne
Ph: 254-724-2006
Utah
  Salt Lake City
 Primary Children's Medical Center
 Phillip Barnette
Ph: 801-662-4700
Vermont
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Virginia
  Falls Church
 Inova Fairfax Hospital
 Clinical Trials Office - Inova Fairfax Hospital
Ph: 703-208-6650
  Richmond
 Virginia Commonwealth University Massey Cancer Center
 Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center
Ph: 804-628-1939
Washington
  Seattle
 Children's Hospital and Regional Medical Center - Seattle
 Julie Park
Ph: 206-987-2106
  Spokane
 Providence Cancer Center at Sacred Heart Medical Center
 Judy Felgenhauer
Ph: 509-474-2777
  Tacoma
 Madigan Army Medical Center - Tacoma
 Melissa Forouhar
Ph: 253-968-6144
Wisconsin
  Green Bay
 St. Vincent Hospital Regional Cancer Center
 Clinical Trials Office - St. Vincent Hospital Regional Cancer Center
Ph: 920-433-8889
  Marshfield
 Marshfield Clinic - Marshfield Center
 Clinical Trials Office - Marshfield Clinic - Marshfield Center
Ph: 800-782-1581 ext. 94457
  Milwaukee
 Midwest Children's Cancer Center at Children's Hospital of Wisconsin
 Michael Kelly
Ph: 414-456-4170
Australia
Western Australia
  Perth
 Princess Margaret Hospital for Children
 Catherine Cole
Ph: 011-6189340-8238
Canada
Alberta
  Edmonton
 University of Alberta Hospital
 Sunil Jayantilal` Desai
Ph: 780-407-8829
British Columbia
  Vancouver
 Children's & Women's Hospital of British Columbia
 Mason Bond
Ph: 604-875-2322
Ontario
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Mariana Silva
Ph: 613-5496666x3833
  London
 Children's Hospital of Western Ontario
 A. Cairney
Ph: 519-685-8494
  Toronto
 Hospital for Sick Children
 Sylvain Baruchel
Ph: 416-813-7795
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 Mansoor Haq
Ph: 306-766-2498
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Christopher Mpofu
Ph: 306-655-2744

Related Information

Featured trial article

Registry Information
Official Title Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL
Trial Start Date 2005-05-30
Trial Completion Date 2008-05-14 (estimated)
Registered in ClinicalTrials.gov NCT00268528
Date Submitted to PDQ 2005-11-28
Information Last Verified 2010-02-09
NCI Grant/Contract Number CA95861

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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