Clinical and Biological Predictors of Therapy-Related Leukemia
N/A
N/A
17 Years
N/A
17 Years
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes, Sarcoma
Both
Leukemia, Myelodysplastic Syndromes, Sarcoma
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 |
