Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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