Myelodysplastic Syndrome Clinical Trial

Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

Summary

RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.

PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

294

Study ID:

NCT00003793

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 95 Locations for this study

See Locations Near You

Southern California Permanente Medical Group
Downey California, 90242, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach California, 90806, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles California, 90095, United States
Children's Hospital Central California
Madera California, 93638, United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States
Stanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford California, 94305, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington Connecticut, 06360, United States
Alfred I. duPont Hospital for Children
Wilmington Delaware, 19899, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers Florida, 33901, United States
University of Florida Shands Cancer Center
Gainesville Florida, 32610, United States
Nemours Children's Clinic
Jacksonville Florida, 32207, United States
Miami Children's Hospital
Miami Florida, 33155, United States
Baptist-South Miami Regional Cancer Program
Miami Florida, 33176, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando Florida, 32803, United States
All Children's Hospital
St. Petersburg Florida, 33701, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa Florida, 33607, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach Florida, 33407, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah Georgia, 31403, United States
Children's Memorial Hospital - Chicago
Chicago Illinois, 60614, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
Kosair Children's Hospital
Louisville Kentucky, 40232, United States
Children's Hospital of New Orleans
New Orleans Louisiana, 70118, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor Maine, 04401, United States
Maine Children's Cancer Program
Scarborough Maine, 04074, United States
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
Children's Hospitals and Clinics of Minneapolis
Minneapolis Minnesota, 55404, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia Missouri, 65203, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St. Louis Missouri, 63110, United States
Hackensack University Medical Center Cancer Center
Hackensack New Jersey, 07601, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx New York, 10461, United States
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn New York, 11220, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
NYU Cancer Institute at New York University Medical Center
New York New York, 10016, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York New York, 10032, United States
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte North Carolina, 28233, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
Children's Hospital Medical Center of Akron
Akron Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Columbus Children's Hospital
Columbus Ohio, 43205, United States
Children's Medical Center - Dayton
Dayton Ohio, 45404, United States
Tod Children's Hospital - Forum Health
Youngstown Ohio, 44501, United States
Oklahoma University Medical Center
Oklahoma City Oklahoma, 73104, United States
Institute of Oncology at Vilnius University
Portland Oregon, 97227, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
St. Christopher's Hospital for Children
Philadelphia Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Greenville Hospital System Cancer Center
Greenville South Carolina, 29605, United States
East Tennessee Children's Hospital
Knoxville Tennessee, 37901, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo Texas, 79106, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Cook Children's Medical Center - Fort Worth
Fort Worth Texas, 76104, United States
Covenant Children's Hospital
Lubbock Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
INOVA Fairfax Hospital
Fairfax Virginia, 22042, United States
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane Washington, 99204, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston West Virginia, 25302, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington West Virginia, 25701, United States
St. Vincent Hospital Regional Cancer Center
Green Bay Wisconsin, 54307, United States
Marshfield Clinic - Marshfield Center
Marshfield Wisconsin, 54449, United States
Office of S. David Lang
Herston, Brisbane Queensland, QLD 4, Australia
Royal Children's Hospital
Parkville Victoria, 3052, Australia
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
Children's & Women's Hospital of British Columbia
Vancouver British Columbia, V6H 3, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
IWK Health Centre
Halifax Nova Scotia, B3K 6, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston Ontario, K7L 5, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy Quebec, G1R 2, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon Saskatchewan, S7N 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Estimated Enrollment:

294

Study ID:

NCT00003793

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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