Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

This study has been completed.

Sponsored by:	Telik
Information provided by:	Telik
ClinicalTrials.gov Identifier:	NCT00035867

Purpose

The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).

Condition	Intervention	Phase
Myelodysplastic Syndromes	Drug: TLK199 HCl Liposomes for Injection	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Further study details as provided by Telik:

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035867

Locations

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

Sponsors and Collaborators

Telik

More Information

Study ID Numbers:	TLK199.1001
Study First Received:	May 6, 2002
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00035867
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Myelodysplastic syndromes
Preleukemia
Precancerous Conditions
Hematologic Diseases

Myelodysplasia
Myelodysplastic Syndromes
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009