Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053287
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2003-01-27
Brief Title:
FludarabineCarboplatinTopotecan wThalidomide for RelapsedRefractory AML CML and MDS
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Study of Fludarabine Carboplatin and Topotecan With Thalidomide for Patients With RelapsedRefractory or High Risk Acute Myelogenous Leukemia Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2010-06
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 Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor Combining chemotherapy with thalidomide may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining fludarabine carboplatin and topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid leukemia chronic myelogenous leukemia or advanced myelodysplastic syndromes
PURPOSE Phase II trial to study the effectiveness of combining fludarabine carboplatin and topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid leukemia chronic myelogenous leukemia or advanced myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Determine the response rate of patients with relapsedrefractory or high-risk acute myeloid leukemia chronic myelogenous leukemia or advanced myelodysplastic syndromes treated with fludarabine carboplatin topotecan and thalidomide
Determine the non-hematologic toxicity profile and time to hematopoietic recovery in patients treated with this regimen
Determine the effects of this regimen on changes in biologic parameters that may predict response in these patients
Correlate bone marrow microvascular density before and after treatment with response in these patients
Determine the prognostic value of pretreatment plasma and serum levels of vascular endothelial growth factor VEGF andor the modulation of serum levels of VEGF during treatment in predicting response in these patients
OUTLINE Patients are stratified according to diagnosis previously untreated acute leukemia vs other
Patients receive fludarabine IV over 5-10 minutes and carboplatin IV over 24 hours on days 1-5 followed by topotecan IV continuously over 72 hours Patients receive oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity
Patients with residual disease on day 16-18 may receive a second course of chemotherapy as above Patients who achieve remission may receive a third course of chemotherapy as above as consolidation beginning 4-8 weeks after completion of prior chemotherapy
Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 40 patients 20 per stratum will be accrued for this study
Determine the response rate of patients with relapsedrefractory or high-risk acute myeloid leukemia chronic myelogenous leukemia or advanced myelodysplastic syndromes treated with fludarabine carboplatin topotecan and thalidomide
Determine the non-hematologic toxicity profile and time to hematopoietic recovery in patients treated with this regimen
Determine the effects of this regimen on changes in biologic parameters that may predict response in these patients
Correlate bone marrow microvascular density before and after treatment with response in these patients
Determine the prognostic value of pretreatment plasma and serum levels of vascular endothelial growth factor VEGF andor the modulation of serum levels of VEGF during treatment in predicting response in these patients
OUTLINE Patients are stratified according to diagnosis previously untreated acute leukemia vs other
Patients receive fludarabine IV over 5-10 minutes and carboplatin IV over 24 hours on days 1-5 followed by topotecan IV continuously over 72 hours Patients receive oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity
Patients with residual disease on day 16-18 may receive a second course of chemotherapy as above Patients who achieve remission may receive a third course of chemotherapy as above as consolidation beginning 4-8 weeks after completion of prior chemotherapy
Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 40 patients 20 per stratum will be accrued for this study
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-1902 | None | None | None |
| CELGENE-CWRU-1902 | None | None | None |
| CASE-1902 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |