Induction Intensification in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002756
First received: November 1, 1999
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them as induction intensification may kill more cancer cells.

PURPOSE: This phase II trial is studying how well induction intensification works in treating infants with newly diagnosed acute lymphocytic leukemia.


Condition Intervention Phase
Leukemia
Biological: filgrastim
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: therapeutic hydrocortisone
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction Intensification in Infant ALL: A Children's Oncology Group Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Feasibility of intensification [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Comparison of event-free survival rates in infants with and without leukemic blasts translocations [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of minimal residual disease at completion of induction, beginning of continuation, and at completion of therapy with patient outcome [ Designated as safety issue: No ]
  • Clinical prognostic features associated with outcome [ Designated as safety issue: No ]
  • Correlation of biologic characteristics of leukemia cells at diagnosis with outcome [ Designated as safety issue: No ]
  • Patterns of gene expression [ Designated as safety issue: No ]

Enrollment: 221
Study Start Date: June 1996
Study Completion Date: March 2012
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemo (Reduced Induction) No BMT (Open February 2004) Biological: filgrastim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: therapeutic hydrocortisone Drug: vincristine sulfate

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia

    • No infants less than 36 weeks' gestation
    • CNS or testicular disease permitted
  • No B-cell ALL or acute myeloid leukemia
  • Previously untreated except for the following:

    • Steroid treatment within 48 hours of diagnosis allowed with physical examination and differential CBC immediately prior to beginning steroids
  • Concurrent registration on protocol POG-9900 (ALL classification study) required
  • Patients registered on POG-9407 are eligible for the pharmacokinetic part of the study

PATIENT CHARACTERISTICS:

Age:

  • Under 1 at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No uncontrolled infection
  • Adequate major organ function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent chronic steroid treatment

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002756

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Locations
United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital and Research Center - Oakland
Oakland, California, United States, 94609-1809
Children's Hospital of Orange County
Orange, California, United States, 92868
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Sutter Cancer Center
Sacramento, California, United States, 95816
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Santa Barbara Cottage Children's Hospital
Santa Barbara, California, United States, 93105
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
Broward General Medical Center Cancer Center
Ft. Lauderdale, Florida, United States, 33316
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States, 33176
Nemours Children's Clinic - Orlando
Orlando, Florida, United States, 32806
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 95813
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712-6297
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9620
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1083
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Floating Hospital for Children at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, United States, 48109-0238
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Hurley Medical Center
Flint, Michigan, United States, 48503
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5341
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
United States, Minnesota
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, United States, 55455
Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2511
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Cardinal Glennon Children's Hospital
St. Louis, Missouri, United States, 63104
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109-2306
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Winthrop University Hospital
Mineola, New York, United States, 11501
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-8174
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-5217
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Toledo Hospital
Toledo, Ohio, United States, 43606
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States, 44501
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland, Oregon, United States, 97227
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, United States, 02903
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37916
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6310
United States, Texas
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States, 79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104-9958
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States, 78229-3993
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05405
United States, Virginia
INOVA Fairfax Hospital
Fairfax, Virginia, United States, 22031
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507-1971
Naval Medical Center - Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24029
United States, Washington
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99220-2555
United States, West Virginia
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States, 25302
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, 1205
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Zoann E. Dreyer, MD Texas Children's Cancer Center
  More Information

Additional Information:
Publications:
Robinson BW, Devidas M, Carroll AJ, et al.: Specific MLL partner genes in infant acute lymphoblastic leukemia (ALL) associated with outcome are linked to age and white blood cell count (WBC) at diagnosis: A report on the Children's Oncology Group (COG) P9407 trial. [Abstract] Blood 114 (22): A-907, 2009.

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00002756     History of Changes
Other Study ID Numbers: P9407, COG-P9407, POG-9407, CDR0000064693
Study First Received: November 1, 1999
Last Updated: February 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
untreated childhood acute lymphoblastic leukemia
acute undifferentiated leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Methotrexate
Asparaginase
Vincristine
Daunorubicin
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014