Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002818
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2000-08-03
Brief Title:
High-Dose Cytarabine Plus Deoxycytidine in Treating With Acute Myelogenous Leukemia or Other Hematologic Malignancies
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I and Clinical Pharmacokinetic De-Escalation Study of 2-Deoxycitidine Administered as a Continuous Infusion in Conjunction With a Continuous Infusion of High-Dose ARA-C in Patients With Refractory Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2015-12
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 Deoxycytidine may protect patients from the side effects of high-dose cytarabine
PURPOSE Phase I trial to study the effectiveness of high-dose cytarabine given with deoxycytidine in treating patients who have refractory acute myelogenous leukemia or other lymphoma or leukemia
PURPOSE Phase I trial to study the effectiveness of high-dose cytarabine given with deoxycytidine in treating patients who have refractory acute myelogenous leukemia or other lymphoma or leukemia
Detailed Description:
OBJECTIVES I Estimate the lowest dose of deoxycytidine dC that can be given as a host protective agent in conjunction with high dose cytarabine HD ARA-C in patients with refractory acute myelogenous leukemia or other hematologic malignancies II Determine the maximum tolerated dose and dose-limiting toxic effects of HD ARA-CdC in these patients III Characterize the pharmacokinetics of continuously administered HD ARA-CdC in these patients IV Characterize when possible the pharmacodynamics of HD ARA-C dC and their metabolites in blasts obtained from leukemic patients participating in this trial V Recommend the lowest possible dose of dC that can be given in combination with HD ARA-C in future phase II trials
OUTLINE This is a dose escalation study Patients receive deoxycytidine IV over 120 hours Beginning 12 hours after initiation of deoxycytidine patients receive high dose cytarabine IV over 96 hours Patients achieving complete response receive no further therapy Patients achieving partial response or initial complete response and subsequent relapse receive an additional course of therapy Cohorts of 3-6 patients receive escalating doses of deoxycytidine and high dose cytarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL Approximately 24-30 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive deoxycytidine IV over 120 hours Beginning 12 hours after initiation of deoxycytidine patients receive high dose cytarabine IV over 96 hours Patients achieving complete response receive no further therapy Patients achieving partial response or initial complete response and subsequent relapse receive an additional course of therapy Cohorts of 3-6 patients receive escalating doses of deoxycytidine and high dose cytarabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL Approximately 24-30 patients 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 |
|---|---|---|---|
| P30CA016059 | NIH | None | None |
| MCV-MCC-9409-2CC | REGISTRY | None | None |
| VCU-FDR000637 | OTHER | None | None |
| NCI-V96-0966 | REGISTRY | ClinicalTrialsgov | httpsreporternihgovquickSearchP30CA016059 |