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Spots Global Cancer Trial Database for Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

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Trial Identification

Brief Title: Gemtuzumab Ozogamicin in Treating Young Patients With Newly Diagnosed Acute Myeloid Leukemia Undergoing Remission Induction and Intensification Therapy

Official Title: Treatment of Newly Diagnosed Childhood Acute Myeloid Leukemia (AML) Using Intensive MRC-Based Therapy and Gemtuzumab Ozogamicin (GMTZ): A COG Pilot Study

Study ID: NCT00070174

Conditions

Leukemia

Study Description

Brief Summary: RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as gemtuzumab ozogamicin, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well gemtuzumab ozogamicin works in treating young patients who are undergoing remission induction, intensification therapy, and allogeneic bone marrow transplant for newly diagnosed acute myeloid leukemia.

Detailed Description: OBJECTIVES: Primary * Determine the safety of gemtuzumab ozogamicin in children with newly diagnosed acute myeloid leukemia undergoing intensive remission induction and intensification therapy. * Determine the complete remission rate of patients treated with this regimen. Secondary * Determine the feasibility of performing biological studies (e.g., FLT3-ITD and MRD) for risk group stratification in these patients. * Determine the effect of karyotypic abnormalities on survival in patients treated with this regimen. OUTLINE: This is a multicenter study. * Induction I: Patients receive high-dose cytarabine (ARA-C) IV twice daily on days 1-10; daunorubicin IV over 6 hours on days 1, 3, and 5; etoposide IV over 4 hours on days 1-5; and gemtuzumab ozogamicin IV over 2 hours on day 6. Patients with CNS-negative disease receive ARA-C intrathecally (IT) on day 1. Patients with CNS-positive disease receive ARA-C IT twice weekly for 2-3 weeks. Between days 28-35, patients are evaluated. Patients achieving remission or who have no more than 20% blasts proceed to induction II. * Induction II: Patients receive ARA-C IV twice daily on days 1-8; ARA-C IT on day 1; and daunorubicin IV and etoposide IV as in induction I. Between days 28-35 patients are evaluated. Patients achieving complete remission proceed to intensification course I. * Intensification course I: Patients receive ARA-C IV over 1 hour twice daily on days 1-5; ARA-C IT as in induction II; and etoposide IV over 1 hour on days 1-5. Patients are evaluated at day 28. Patients with a 5/6 or 6/6 matched family donor proceed to allogeneic bone marrow transplantation. All other patients in complete remission proceed to intensification course II. * Intensification course II: Patients receive ARA-C IV over 2 hours twice daily on days 1-4; ARA-C IT as in induction II; mitoxantrone IV over 1 hour on days 3-6; and gemtuzumab ozogamicin IV over 2 hours on day 7. Patients are evaluated on day 28 and then proceed to intensification course III. * Intensification course III: Patients receive ARA-C IV over 3 hours twice daily on days 1, 2, 8, and 9 and asparaginase intramuscularly on days 2 and 9. * Allogeneic bone marrow transplantation: Patients receive a preparative regimen comprising busulfan IV over 2 hours 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour once daily on days -5 to -2. Allogeneic stem cells are infused on day 0. * Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily on days -1 to 50 and methotrexate IV once daily on days 1, 3, 6, and 11. In all courses, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 6 months, every 2 months for 6 months, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Comprehensive Cancer Center at University of Alabama at Birmingham, Birmingham, Alabama, United States

Phoenix Children's Hospital, Phoenix, Arizona, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Southern California Permanente Medical Group, Downey, California, United States

Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, United States

Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach, California, United States

Children's Hospital Los Angeles, Los Angeles, California, United States

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, United States

Children's Hospital Central California, Madera, California, United States

Children's Hospital and Research Center - Oakland, Oakland, California, United States

Children's Hospital of Orange County, Orange, California, United States

University of California Davis Cancer Center, Sacramento, California, United States

Sutter Cancer Center, Sacramento, California, United States

Kaiser Permanente Medical Center - Oakland, Sacramento, California, United States

Children's Hospital and Health Center - San Diego, San Diego, California, United States

Children's Hospital Cancer Center, Denver, Colorado, United States

Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Hartford, Connecticut, United States

Alfred I. duPont Hospital for Children, Wilmington, Delaware, United States

Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, United States

Children's National Medical Center, Washington, District of Columbia, United States

Broward General Medical Center Cancer Center, Ft. Lauderdale, Florida, United States

Lee Cancer Care of Lee Memorial Health System, Ft. Myers, Florida, United States

University of Florida Shands Cancer Center, Gainesville, Florida, United States

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States

Nemours Children's Clinic, Jacksonville, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Miami Children's Hospital, Miami, Florida, United States

Baptist-South Miami Regional Cancer Program, Miami, Florida, United States

Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States

M.D. Anderson Cancer Center - Orlando, Orlando, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital, Pensacola, Florida, United States

All Children's Hospital, St. Petersburg, Florida, United States

St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States

Kaplan Cancer Center at St. Mary's Medical Center, West Palm Beach, Florida, United States

Emory University Hospital - Atlanta, Atlanta, Georgia, United States

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States

Cancer Research Center of Hawaii, Honolulu, Hawaii, United States

St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, United States

Children's Memorial Hospital - Chicago, Chicago, Illinois, United States

University of Chicago Cancer Research Center, Chicago, Illinois, United States

Lutheran General Cancer Care Center, Park Ridge, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Indiana University Cancer Center, Indianapolis, Indiana, United States

St. Vincent Indianapolis Hospital, Indianapolis, Indiana, United States

Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Wesley Medical Center, Wichita, Kansas, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States

Kosair Children's Hospital, Louisville, Kentucky, United States

CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States

Maine Children's Cancer Program, Scarborough, Maine, United States

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Floating Hospital for Children, Boston, Massachusetts, United States

C.S. Mott Children's Hospital at University of Michigan, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Breslin Cancer Center at Ingham Regional Medical Center, East Lansing, Michigan, United States

Spectrum Health Cancer Care - Butterworth Campus, Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Point Woods, Michigan, United States

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis, Minnesota, United States

Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Keesler Medical Center - Keesler Air Force Base, Keesler AFB, Mississippi, United States

Children's Mercy Hospital, Kansas City, Missouri, United States

Cardinal Glennon Children's Hospital, St. Louis, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, United States

Children's Hospital of Omaha, Omaha, Nebraska, United States

Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States

Hackensack University Medical Center, Hackensack, New Jersey, United States

St. Barnabas Medical Center, Livingston, New Jersey, United States

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center, Newark, New Jersey, United States

St. Joseph's Hospital and Medical Center, Paterson, New Jersey, United States

University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, United States

Brooklyn Hospital Center, Brooklyn, New York, United States

Maimonides Medical Center, Brooklyn, New York, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Winthrop University Hospital, Mineola, New York, United States

Schneider Children's Hospital, New Hyde Park, New York, United States

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

SUNY Upstate Medical University Hospital, Syracuse, New York, United States

New York Medical College, Valhalla, New York, United States

Mission Hospitals - Memorial Campus, Asheville, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States

Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States

Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital, Greenville, North Carolina, United States

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

Children's Hospital Medical Center of Akron, Akron, Ohio, United States

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States

Columbus Children's Hospital, Columbus, Ohio, United States

Children's Medical Center - Dayton, Dayton, Ohio, United States

Toledo Hospital, Toledo, Ohio, United States

Medical College of Ohio Cancer Institute, Toledo, Ohio, United States

Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States

Cancer Institute at Oregon Health and Science University, Portland, Oregon, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States

Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, United States

Children's Hospital of Austin, Austin, Texas, United States

Driscoll Children's Hospital, Corpus Christi, Texas, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States

Covenant Children's Hospital, Lubbock, Texas, United States

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

Methodist Children's Hospital of South Texas, San Antonio, Texas, United States

CCOP - Scott and White Hospital, Temple, Texas, United States

Primary Children's Medical Center, Salt Lake City, Utah, United States

Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States

INOVA Fairfax Hospital, Fairfax, Virginia, United States

Massey Cancer Center at Virginia Commonwealth University, Richmond, Virginia, United States

Carilion Cancer Center of Western Virginia, Roanoke, Virginia, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States

Mary Bridge Children's Hospital and Health Center - Tacoma, Tacoma, Washington, United States

Madigan Army Medical Center, Tacoma, Washington, United States

West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, United States

Cabell Huntington Hospital, Huntington, West Virginia, United States

St. Vincent Hospital, Green Bay, Wisconsin, United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States

Westmead Hospital, Westmead, New South Wales, Australia

Office of S. David Lang, Herston, Brisbane, Queensland, Australia

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Alberta Children's Hospital, Calgary, Alberta, Canada

Children's & Women's Hospital of British Columbia, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, Canada

IWK Health Centre, Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

McGill Cancer Centre at McGill University, Montreal, Quebec, Canada

Hopital Sainte Justine, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec, Ste-Foy, Quebec, Canada

San Jorge Children's Hospital, Santurce, , Puerto Rico

Swiss Pediatric Oncology Group Bern, Bern, Chihuahua, Switzerland

Contact Details

Name: Janet Franklin, MD, MPH

Affiliation: Children's Hospital Los Angeles

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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