STI571 in Treating Patients With Recurrent Leukemia

NCT00004932 | Completed Phase 1 DMC

• 5 other identifiers: P9973COG-P9973POG-9973CCG-P9973CDR0000067616
• Study Type: interventional
• Target: 31
• Locations: 7 countries
• Sites: 235

Brief Summary

RATIONALE: Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia. PURPOSE: Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia.

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; relapsing chronic myelogenous leukemia; chronic myelogenous leukemia, BCR-ABL1 positive; childhood chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

• Survival

  To estimate the maximum tolerated dose (MTD) of STI571 administered orally once daily without interruption to children with recurrent Ph+ leukemia.

  Length of study

Secondary Outcomes (3)

• Dose-limiting toxicities

  Length of study

• Characterize the pharmacokinetic behavior

  Length of study

• Define the anti-leukemic activity of STI571

  Length of study

Study Arms (4)

260 mg/m2 imatinib mesylate (ST571)

EXPERIMENTAL

Drug: imatinib mesylate

340 mg/m2 imatinib mesylate (ST571)

EXPERIMENTAL

Drug: imatinib mesylate

440 mg/m2 imatinib mesylate (ST571)

EXPERIMENTAL

Drug: imatinib mesylate

570 mg/m2 imatinib mesylate (ST571)

EXPERIMENTAL

Drug: imatinib mesylate

Interventions

imatinib mesylate DRUG

Also known as: CGP 57148, IND # 55666

260 mg/m2 imatinib mesylate (ST571); 340 mg/m2 imatinib mesylate (ST571); 440 mg/m2 imatinib mesylate (ST571); 570 mg/m2 imatinib mesylate (ST571)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Recurrent Philadelphia (Ph) chromosome-positive leukemia * Recurrent or refractory acute lymphoblastic or myeloblastic leukemia OR * Chronic myelogenous leukemia with resistance to interferon alfa with any of the following: * WBC at least 20,000/mm\^3 after at least 3 months of interferon therapy * At least 100% increase in WBC to at least 20,000/mm\^3 confirmed over 2 weeks while receiving interferon alfa * At least 66% Ph chromosome-positive cells after 1 year of interferon therapy * At least 30% increase in number of Ph chromosome-positive cells after an interferon-induced response while continuing interferon therapy PATIENT CHARACTERISTICS: Age: * Under 22 Performance status: * Karnofsky 50-100% if over 10 years of age OR * Lansky 50-100% if 10 years of age and under Life expectancy: * At least 8 weeks Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 1.5 times normal * SGPT less than 3 times normal * Albumin greater than 2 g/dL Renal: * Creatinine no greater than 1.5 times normal OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * If prior allogeneic stem cell transplantation, no uncontrolled graft-versus -host disease * No seizure disorder if on anticonvulsants * No uncontrolled infection * No CNS toxicity greater than grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 1 week since prior biologic therapy and recovered * At least 3 months since prior stem cell transplantation (SCT) * At least 1 week since prior growth factors * At least 1 week since prior interferon alfa Chemotherapy: * Recovered from prior chemotherapy * At least 6 weeks since prior busulfan and nitrosoureas * At least 2 weeks since prior homoharringtonine * At least 1 week since low-dose cytarabine * At least 2 weeks since prior moderate-dose cytarabine * At least 4 weeks since prior high-dose cytarabine * At least 3 weeks since all other prior cytotoxic chemotherapies * No prior hydroxyurea Endocrine therapy: * Must be on a stable dose of steroids if received prior allogeneic SCT Radiotherapy: * Recovered from prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to 50% or more of the pelvis * At least 6 weeks since other prior substantial bone marrow radiotherapy Surgery: * Not specified Other: * No other concurrent investigational agents * No concurrent anticonvulsants

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (235)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35233, United States

Location

University of South Alabama Medical Center

Mobile, Alabama, 36604, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016-7710, United States

Location

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Southern California Permanente Medical Group

Downey, California, 90242, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Jonathan Jaques Children's Cancer Center

Long Beach, California, 90801-1428, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital of Oakland

Oakland, California, 94609-1809, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, 94304, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

San Diego, California, 92120, United States

Location

Children's Hospital San Diego

San Diego, California, 92123-4282, United States

Location

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, 94115, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94143-0128, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93102, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051-5386, United States

Location

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

Children's Hospital of Denver

Denver, Colorado, 80218-1088, United States

Location

Childhood Hematology/Oncology Associates

Denver, Colorado, 80218, United States

Location

Presbyterian-St Luke's Medical Center

Denver, Colorado, 80218, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Alfred I. Dupont Institute

Wilmington, Delaware, 19899, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Walter Reed Army Medical Center

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

Location

Broward General Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Children's Hospital of Southwest Florida

Fort Myers, Florida, 33908, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

Joe DiMaggio Children's Hospital at Memorial

Hollywood, Florida, 33021, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

University of Miami-Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Miami Children's Hospital

Miami, Florida, 33155-4069, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176-2197, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32803, United States

Location

Nemours Children's Clinic-Orlando

Orlando, Florida, 32806, United States

Location

Sacred Heart Children's Hospital

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Tampa Children's Hospital

Tampa, Florida, 33677-4227, United States

Location

St. Mary's Hospital

West Palm Beach, Florida, 33407, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta - Scottish Rite

Atlanta, Georgia, 30342, United States

Location

Medical College of Georgia Comprehensive Cancer Center

Augusta, Georgia, 30912-4000, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Memorial Health University Medical Center, Inc.

Savannah, Georgia, 31403-3089, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

Tripler Army Medical Center

Honolulu, Hawaii, 96859-5000, United States

Location

Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60601, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Hope Children's Hospital

Oak Lawn, Illinois, 60453, United States

Location

Lutheran General Hospital

Park Ridge, Illinois, 60068-1174, United States

Location

Saint Jude Midwest Affiliate

Peoria, Illinois, 61637, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9658, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

St. Vincent Hospital and Health Care Center

Indianapolis, Indiana, 46260, United States

Location

Raymond Blank Memorial Hospital for Children

Des Moines, Iowa, 50308, United States

Location

John Stoddard Cancer Center

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0284, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202-3830, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Children's Hospital of New Orleans

New Orleans, Louisiana, 70118, United States

Location

Ochsner Clinic

New Orleans, Louisiana, 70121, United States

Location

Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Maine Children's Cancer Program

Scarborough, Maine, 04074, United States

Location

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201-1595, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21225, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Floating Hospital for Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01107, United States

Location

University of Massachusetts Memorial Medical Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

Mott Children's Hospital

Ann Arbor, Michigan, 48109-0914, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Spectrum Health and DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

CCOP - Beaumont

Royal Oak, Michigan, 48073-6769, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073-6769, United States

Location

St. Mary's/Duluth Clinic Cancer Center

Duluth, Minnesota, 55805-1983, United States

Location

Children's Hospitals and Clinics - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Children's Hospital of Omaha

Omaha, Nebraska, 68114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-2168, United States

Location

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109-2306, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112-2094, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Atlantic Health System

Summit, New Jersey, 07901, United States

Location

University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Brooklyn Hospital Center

Brooklyn, New York, 11201, United States

Location

State University of New York Health Science Center at Brooklyn College of Medicine

Brooklyn, New York, 11203, United States

Location

Brookdale University Hospital and Medical Center

Brooklyn, New York, 11212, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11042, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021-4885, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

James P. Wilmot Cancer Center

Rochester, New York, 14642, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-7775, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Mission Saint Joseph's Health System

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Presbyterian Healthcare

Charlotte, North Carolina, 28233-3549, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

East Carolina University School of Medicine

Greenville, North Carolina, 27858-4354, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1081, United States

Location

Dakota Cancer Institute

Fargo, North Dakota, 58103-4940, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Children's Hospital of Columbus

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404, United States

Location

Toledo Children's Hospital

Toledo, Ohio, 43601, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Forum Health-Tod Childrens Hospital

Youngstown, Ohio, 44501, United States

Location

Children's Hospital of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Natalie Warren Bryant Cancer Center

Tulsa, Oklahoma, 74136, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97201-3098, United States

Location

Legacy Emanuel Hospital and Health Center

Portland, Oregon, 97227, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-1320, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134-1095, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02818, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Palmetto Health South Carolina Cancer Center

Columbia, South Carolina, 29203, United States

Location

Children's Hospital of Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105-1080, United States

Location

Sioux Valley Hospital

Sioux Falls, South Dakota, 57117, United States

Location

East Tennessee State University Cancer Center at JCMC

Johnson City, Tennessee, 37604, United States

Location

East Tennessee Children's Hospital

Knoxville, Tennessee, 37901, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Children's Hospital of Austin

Austin, Texas, 78701, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

San Antonio Military Pediatric Cancer and Blood Disorders Center

Lackland Air Force Base, Texas, 78236-5300, United States

Location

Covenant Children's Hospital

Lubbock, Texas, 79410, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

Methodist Health Care System

San Antonio, Texas, 78229-3902, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Vermont Cancer Center

Burlington, Vermont, 05401-3498, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Naval Medical Center, Portsmouth

Portsmouth, Virginia, 23708-5100, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Carilion Medical Center for Children

Roanoke, Virginia, 24013, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Group Health Cooperative

Seattle, Washington, 98112, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Mary Bridge Children's Health Center

Tacoma, Washington, 98415-0299, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

West Virginia University - Charleston

Charleston, West Virginia, 25302, United States

Location

Cabell-Huntington Hospital, Inc

Huntington, West Virginia, 25701, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

St. Vincent Hospital

Green Bay, Wisconsin, 54307-9070, United States

Location

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-0001, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449-5772, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

Location

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Royal Children's Hospital

Brisbane, Queensland, 4029, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Alberta Children's Hospital

Calgary, Alberta, T2T 5C7, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Janeway Children's Health and Rehabilitation Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital of Western Ontario

London, Ontario, N6C 2V5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

McGill University Health Center - Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Laval University Medical Center

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Centre Hospitalier de L'Universite Laval

Sainte-Foy, Quebec, GIV 4G2, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Academisch Ziekenhuis Groningen

Groningen, 9700 RB, Netherlands

Location

Starship Children's Hospital

Auckland, New Zealand

Location

University of Puerto Rico School of Medicine Medical Sciences Campus

San Juan, 00936-5067, Puerto Rico

Location

San Jorge Childrens Hospital

Santurce, 00912, Puerto Rico

Location

Swiss Pediatric Oncology Group Bern

Bern, CH 3010, Switzerland

Location

Swiss Pediatric Oncology Group Geneva

Geneva, CH 1211, Switzerland

Location

Swiss Pediatric Oncology Group Lausanne

Lausanne, CH 1011, Switzerland

Location

Related Publications (2)

• Champagne MA, Capdeville R, Krailo M, Qu W, Peng B, Rosamilia M, Therrien M, Zoellner U, Blaney SM, Bernstein M; Children's Oncology Group phase 1 study. Imatinib mesylate (STI571) for treatment of children with Philadelphia chromosome-positive leukemia: results from a Children's Oncology Group phase 1 study. Blood. 2004 Nov 1;104(9):2655-60. doi: 10.1182/blood-2003-09-3032. Epub 2004 Jul 1.

  PMID: 15231574 RESULT

• Champagne MA, Hershon L, Rosamilia M, et al.: STI571 in the Treatment of Pediatric Philadelphia (Ph+) Chromosome-Positive Leukemia: A Children's Oncology Group Phase 1 Study (P-9973). [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1466, 2001.

  RESULT

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Martin Champagne, MD

  Hopital Sainte Justine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

NL (1); NZ (1); CA (16); CH (3); AU (6); US (206); PR (2)