Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098683
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2004-12-07
Brief Title:
Amifostine in Treating Young Patients With Newly Diagnosed De Novo Myelodysplastic Syndromes
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study Of Amifostine In Children With Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COG-AAML0121 | OTHER | Childrens Oncology Group | None |
| CDR0000398140 | OTHER | None | None |