Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
- Conditions
- Myelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms
- Registration Number
- NCT00098683
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as amifostine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well amifostine works in treating young patients with newly diagnosed de novo myelodysplastic syndromes.
- Detailed Description
OBJECTIVES:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and efficacy Hematological effects (complete and partial response)
- Secondary Outcome Measures
Name Time Method Efficacy Duration of progression-free remission Effect of karyotypic abnormalities on survival Effect of the number of cytopenias on survival Correlation of the duration of time from diagnosis of myelodysplastic syndromes until conversion to acute myeloid leukemia
Trial Locations
- Locations (85)
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, 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
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Overlook Hospital
🇺🇸Morristown, New Jersey, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Children's Hospital of Austin
🇺🇸Austin, Texas, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Maimonides Cancer Center at Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Tod Children's Hospital - Forum Health
🇺🇸Youngstown, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Miami Children's Hospital
🇺🇸Miami, 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
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
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
🇺🇸Amarillo, 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
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia