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Clinical and Biological Predictors of Therapy-Related Leukemia


N/A
N/A
17 Years
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes, Sarcoma

Thank you

Trial Information

Clinical and Biological Predictors of Therapy-Related Leukemia


OBJECTIVES:

- Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome
or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy
for sarcoma.

- Identify patients who are at increased risk of t-MDS/AML during or after therapy.

OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or
transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after
therapy.

Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency
(glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras
mutation detection (single strand conformation polymorphism and sequencing of mutant
alleles).

Patients do not receive the results of the genetic testing and the results do not influence
the type or duration of treatment.

PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of sarcoma including:

- Rhabdomyosarcoma

- Ewing's sarcoma

- Primitive neuroectodermal tumor

- Fibrosarcoma

- Malignant peripheral nerve sheath tumor

- Synovial cell sarcoma

- Osteosarcoma

- Other soft tissue sarcoma

- Must be currently receiving intensive or high-dose chemotherapy for sarcoma

PATIENT CHARACTERISTICS:

Age:

- Children

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Stella M. Davies, MBBS, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Medical Center, Cincinnati

Authority:

United States: Federal Government

Study ID:

CDR0000066936

NCT ID:

NCT00003793

Start Date:

December 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Sarcoma
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • localized osteosarcoma
  • metastatic osteosarcoma
  • childhood soft tissue sarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • childhood fibrosarcoma
  • childhood synovial sarcoma
  • childhood neurofibrosarcoma
  • previously untreated childhood rhabdomyosarcoma
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Rhabdomyosarcoma
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
CCOP - MeritCare HospitalFargo, North Dakota  58122
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Blank Children's HospitalDes Moines, Iowa  50309
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
C.S. Mott Children's Hospital at University of MichiganAnn Arbor, Michigan  48109-0238
Children's Hospitals and Clinics of MinneapolisMinneapolis, Minnesota  55404
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Mount Sinai Medical CenterNew York, New York  10029
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Maimonides Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Columbus Children's HospitalColumbus, Ohio  43205-2696
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
Stanford Comprehensive Cancer Center at Stanford University Medical CenterStanford, California  94305