Clinical Trial: Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome

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 Summary:

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 toxi
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Hematological effects (complete and partial response)
  • Safety and efficacy


Original Primary Outcome:

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: December 7, 2004
Date Started: January 2005
Date Completion:
Last Updated: February 11, 2014
Last Verified: February 2014