Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003675
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
1999-11-01
Brief Title:
Topotecan in Treating Patients With Myelodysplastic Syndrome
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Randomized Phase II Trial of Oral Topotecan Given Twice a Day for 5 Days or Once a Day for 10 Days to Patients With Myelodysplastic Syndromes MDS
Status:
COMPLETED
Status Verified Date:
2016-07
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 use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Randomized phase II trial to study the effectiveness of topotecan in treating patients who have myelodysplastic syndrome
PURPOSE Randomized phase II trial to study the effectiveness of topotecan in treating patients who have myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Estimate complete or partial remission hematologic improvement and cytogenic response rate when oral topotecan is given twice a day for 5 days versus once a day for 10 days to patients with myelodysplastic syndromes II Evaluate the safety and toxicity of oral topotecan in these patients III Evaluate whether there are morphologic andor cytogenetic subsets of the myelodysplastic syndromes that will respond optimally to this regimen IV Evaluate the change in the percentage of bone marrow blast cells in these patients during treatment V Evaluate the time to transformation to acute myeloid leukemia AML or death in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to FAB subtype 1 Refractory anemia with excess blasts 2 Refractory anemia with excess blasts in transformation 3 Chronic myelomonocytic leukemia 4 Refractory anemia refractory anemia with ringed sideroblasts and refractory cytopenia with multilineage dysplasia Patients are randomized to receive oral topotecan either twice daily for 5 days or once daily for 10 days Courses are repeated every 21 days Patients are evaluated for hematologic response after the initial 2 courses and then every 4 courses If a partial response or hematologic improvement is observed treatment continues until disease progression to acute myeloid leukemia relapse death or irreversible toxicity Patients who achieve a complete response receive an additional 2 courses of therapy before discontinuation of protocol treatment Patients are followed every 3 months for 2 years then every year for an additional 3 years and at time of progression
PROJECTED ACCRUAL A total of 90 patients 45 per arm will be accrued for this study within 13 months
OUTLINE This is a randomized multicenter study Patients are stratified according to FAB subtype 1 Refractory anemia with excess blasts 2 Refractory anemia with excess blasts in transformation 3 Chronic myelomonocytic leukemia 4 Refractory anemia refractory anemia with ringed sideroblasts and refractory cytopenia with multilineage dysplasia Patients are randomized to receive oral topotecan either twice daily for 5 days or once daily for 10 days Courses are repeated every 21 days Patients are evaluated for hematologic response after the initial 2 courses and then every 4 courses If a partial response or hematologic improvement is observed treatment continues until disease progression to acute myeloid leukemia relapse death or irreversible toxicity Patients who achieve a complete response receive an additional 2 courses of therapy before discontinuation of protocol treatment Patients are followed every 3 months for 2 years then every year for an additional 3 years and at time of progression
PROJECTED ACCRUAL A total of 90 patients 45 per arm will be accrued for this study within 13 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CLB-19803 | None | None | None |
| CDR0000066776 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |