Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
NCT ID: NCT00098683
Last Updated: 2014-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2005-01-31
2009-10-31
Brief Summary
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PURPOSE: This phase II trial is studying how well amifostine works in treating young patients with newly diagnosed de novo myelodysplastic syndromes.
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Detailed Description
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Primary
* Determine the hematologic effects of amifostine, in terms of, complete and partial response, in pediatric patients with newly diagnosed de novo myelodysplastic syndromes (MDS).
* Determine the safety and efficacy of this drug in these patients.
Secondary
* Determine the efficacy of this drug in preventing conversion of MDS to acute myeloid leukemia (AML) in terms of the proportion of patients who remain free of AML at the completion of study treatment.
* Determine the duration of progression-free remission from MDS conversion to AML in patients treated with this drug.
* Determine the effect of karyotypic abnormalities on survival and the duration from diagnosis of MDS until conversion to AML in patients treated with this drug.
* Determine the effect of bone marrow blast count on survival and the duration from diagnosis of MDS until conversion to AML in patients treated with this drug.
* Determine the effect of the number of cytopenias on survival in patients treated with this drug.
* Correlate the duration of time from diagnosis of MDS until conversion to AML with survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive amifostine IV over 1-3 minutes on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease who are planning to undergo matched donor bone marrow or cord blood transplantation continue therapy until transplantation. Patients with stable or responding disease who are not undergoing transplantation may receive up to 4 additional courses of amifostine in the absence of disease progression or unacceptable toxicity.
Following completion of therapy with amifostine, patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 5-10 months.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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amifostine trihydrate
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of myelodysplastic syndromes (MDS)
* One of the following subtypes:
* Refractory anemia (RA)
* RA with ringed sideroblasts
* RA with excess blasts
* Refractory cytopenia with multilineage dysplasia (RCMD)
* RCMD and ringed sideroblasts
* MDS, unclassified
* MDS associated with isolated del 5(q)
* De novo disease
* No treatment-induced MDS
* No juvenile myelomonocytic leukemia
* No Down syndrome, Fanconi's anemia, or other inherited forms of hypoplastic bone marrow failure
PATIENT CHARACTERISTICS:
Age
* 1 to 21 at original diagnosis
Performance status
* Karnofsky 50-100% (patients \> 16 years of age)
* Lansky 50-100% (patients 1 to 16 years of age)
Life expectancy
* At least 8 weeks
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT \< 2.5 times ULN
Renal
* Radioisotope glomerular filtration rate ≥ 60 mL/min OR
* Creatinine clearance \> 60 mL/min (based on Schwartz formula)
* Calcium normal
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Serum electrolytes normal
* Phosphorus normal
* Magnesium normal
* Glucose normal
* No other concurrent malignancy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 8 weeks since prior growth factors
* No concurrent growth factors
* No concurrent hematopoietic stem cell transplantation
* No concurrent immunomodulating agents
Chemotherapy
* No prior amifostine
* No other concurrent anticancer chemotherapy
Endocrine therapy
* No concurrent daily steroid therapy
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior therapy for MDS
1 Year
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Prasad Mathew, MD
Role: STUDY_CHAIR
University of New Mexico Cancer Center
Robert J. Arceci, MD, PhD
Role:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Central California
Madera, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States
Overlook Hospital
Morristown, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Maimonides Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Tod Children's Hospital - Forum Health
Youngstown, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
Amarillo, Texas, United States
Children's Hospital of Austin
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
University of Alberta Hospital
Edmonton, Alberta, Canada
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
San Jorge Children's Hospital
Santurce, , Puerto Rico
Countries
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References
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Mathew P, Gerbing R, Alonzo TA, Wallas T, Gong JZ, Jasty R, Jorstad DT, Raimondi SC, Chavez CM, Eisenberg NL, Hirsch B, Gamis A, Smith FO, Arceci RJ. A phase II study of amifostine in children with myelodysplastic syndrome: a report from the Children's Oncology Group study (AAML0121). Pediatr Blood Cancer. 2011 Dec 15;57(7):1230-2. doi: 10.1002/pbc.23164. Epub 2011 Jun 16.
Other Identifiers
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CDR0000398140
Identifier Type: OTHER
Identifier Source: secondary_id
COG-AAML0121
Identifier Type: OTHER
Identifier Source: secondary_id
AAML0121
Identifier Type: -
Identifier Source: org_study_id
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