Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002588
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Trial of Sequential TopotecanNSC 609699and Etoposide for Patients With Relapsed Refractoryor High Risk Acute Myeloid or Lymphoid Leukemia
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 Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of topotecan and etoposide in treating patients who have recurrent or refractory leukemia
PURPOSE Phase I trial to study the effectiveness of topotecan and etoposide in treating patients who have recurrent or refractory leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of topotecan when combined with etoposide in patients with relapsed or refractory acute myelogenous leukemia acute lymphoblastic leukemia or blastic phase chronic myelogenous leukemia II Determine the toxicity of this regimen in these patients III Measure serum levels of topotecan at steady state and correlate them with any change in topoisomerase II content in leukemic blasts IV Assess whether it is feasible to correlate any upregulation of topoisomerase II expression with tumor response to etoposide in subsequent Phase II studies V Assess whether levels of pretreatment expression of topoisomerases I and II in leukemic cells are predictive of clinical response VI Assess whether it is feasible to develop a pharmacodynamic assay based on posttreatment apoptotic changes in leukemic blasts and whether this could be correlated with tumor response in subsequent phase II trials VII Determine the response in patients treated with this regimen
OUTLINE Induction 2-Drug Combination Chemotherapy Topotecan TOPO NSC-609699 Etoposide VP-16 NSC-141540 Consolidation 2-Drug Combination Chemotherapy TOPO VP-16
PROJECTED ACCRUAL 15-23 patients will be accrued in approximately 18 months
OUTLINE Induction 2-Drug Combination Chemotherapy Topotecan TOPO NSC-609699 Etoposide VP-16 NSC-141540 Consolidation 2-Drug Combination Chemotherapy TOPO VP-16
PROJECTED ACCRUAL 15-23 patients will be accrued in approximately 18 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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CWRU-ICC-2994 | OTHER | None | None |
| NCI-T94-0078D | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |