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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 Institute Buffalo, New York  14263
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Hurley Medical Center Flint, Michigan  48503
Medical City Dallas Hospital Dallas, Texas  75230
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
Children's Memorial Hospital - Chicago Chicago, Illinois  60614
Children's Hospital of New Orleans New Orleans, Louisiana  70118
Maine Children's Cancer Program Scarborough, Maine  04074-9308
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
UCSF Comprehensive Cancer Center San Francisco, California  94115
Southern California Permanente Medical Group Downey, California  90242
Children's Hospital Central California Madera, California  93638-8762
Kosair Children's Hospital Louisville, Kentucky  40202-3830
Children's Hospital Medical Center of Akron Akron, Ohio  44308
Children's Medical Center - Dayton Dayton, Ohio  45404
East Tennessee Children's Hospital Knoxville, Tennessee  37901
Covenant Children's Hospital Lubbock, Texas  79410
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital Long Beach, California  90801
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
University of Florida Shands Cancer Center Gainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer Program Miami, Florida  33176
Florida Hospital Cancer Institute at Florida Hospital Orlando Orlando, Florida  32803-1273
St. Joseph's Cancer Institute at St. Joseph's Hospital Tampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical Center West Palm Beach, Florida  33407
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
Blank Children's Hospital Des Moines, Iowa  50309
CancerCare of Maine at Eastern Maine Medial Center Bangor, Maine  04401
C.S. Mott Children's Hospital at University of Michigan Ann Arbor, Michigan  48109-0238
Children's Hospitals and Clinics of Minneapolis Minneapolis, Minnesota  55404
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Mount Sinai Medical Center New York, New York  10029
Stony Brook University Cancer Center Stony Brook, New York  11794-8174
SUNY Upstate Medical University Hospital Syracuse, New York  13210
Presbyterian Cancer Center at Presbyterian Hospital Charlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio  45229-3039
Tod Children's Hospital - Forum Health Youngstown, Ohio  44501
Greenville Hospital System Cancer Center Greenville, South Carolina  29605
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital Huntington, West Virginia  25701
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Jonsson Comprehensive Cancer Center at UCLA Los Angeles, California  90095-1781
Alfred I. duPont Hospital for Children Wilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Washington, District of Columbia  20007
Maimonides Cancer Center at Maimonides Medical Center Brooklyn, New York  11219
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
Columbus Children's Hospital Columbus, Ohio  43205-2696
Institute of Oncology at Vilnius University Portland, Oregon  97227
University of Minnesota Medical Center & Children's Hospital - Fairview Minneapolis, Minnesota  55455
Stanford Comprehensive Cancer Center at Stanford University Medical Center Stanford, California  94305