Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies

Phase 1

Completed

• Conditions: Hematologic Malignancies
• Interventions: Drug: Tezacitabine (FMdC)

• Registration Number: NCT00061620
• Lead Sponsor: M.D. Anderson Cancer Center

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 3/6 patients. The study is ongoing and we are currently evaluating a dose level of 7.5 mg/m2 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 Timeline

• Study Start: 2001-09-06
• Study First Submitted: 2003-05-30
• Study First Submitted QC: 2003-05-30
• Study First Posted: 2003-06-02
• Primary Completion: 2004-02-12
• Study Completion: 2004-02-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tezacitabine	Tezacitabine (FMdC)	Tezacitabine as a bolus infusion daily x 5

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose (MTD)		MTD determination made from dose level without a dose-limiting toxicity (DLT)

Trial Locations

Locations (1)

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States