Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061620
Status:
COMPLETED
Last Update Posted:
2018-11-01
First Post:
2003-05-30
Brief Title:
Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Continuous Infusion Schedule of E-2-Deoxy-2-Fluoromethylene Cytidine Tezacitabine FMdC in Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2018-10
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:
The goal of this clinical research study is to find the highest dose of Tezacitabine FMdC which can be safely given as a continuous infusion by vein to patients with hematologic malignancies The general safety and effectiveness of this drug will also be studied
Detailed Description:
Patients with leukemias that have relapsed from previous therapies have a low cure rate Hence the need to discover new antileukemic agents Tezacitabine is a nucleoside analogue with equivalent or even superior activity when compared with ara-C in leukemic cell lines It has shown significant antitumor activity in vitro and in vivo tumor models Several phase I studies with various dosing schedules have been conducted in solid tumors where the dose-limiting toxicity DLT is mainly myelosuppression usually a favorable feature for development of leukemia In a phase I study in hematological malignancies we used Tezacitabine as a bolus infusion daily x 5 The DLT consisted of grade 3 CNS toxicities and mucositis in 36 patients The study is ongoing and we are currently evaluating a dose level of 75 mgm2 as possible Maximum Tolerated Dose MTD However in view of the fact that tezacitabine is a cell cycle specific agent with a short terminal plasma half-life of 2 to 6 hours a continuous infusion dosing schedule may enhance the activity and reduce the incidence of adverse effects of tezacitabine
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