TLK199 HCl Liposomes for Injection in Myelodysplastic Syndromes - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Myelodysplastic Syndromes

Intervention / Treatment

Drug: TLK199 HCl Liposomes for Injection

Study Type

Interventional

Enrollment

65

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University of Alabama at Birmingham
- California
  - Los Angeles, California, United States, 90404
    - The Angeles Clinic & Research Institute
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago
  - Skokie, Illinois, United States, 60077
    - Midwest Cancer Research Group
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health & Science University
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - The Sarah Cannon Cancer Center
- Texas
  - Dallas, Texas, United States, 75231
    - Texas Cancer Associates
  - Houston, Texas, United States, 77030
    - M.D. Anderson Cancer Center
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of MDS
Adequate liver and kidney function
Ineligible for, or refusing, allogeneic bone marrow transplant
At least 18 years of age
Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry

Exclusion Criteria:

Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
Pregnant or lactating women
History of allergy to eggs
Other investigational drugs within 14 days of study entry
Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
Concomitant steroids or hormones for the treatment of neoplasms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Telik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

May 6, 2002

First Submitted That Met QC Criteria