Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Primary Purpose
Myelodysplastic Syndromes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TLK199 HCl Liposomes for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes
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
Sites / Locations
- University of Alabama at Birmingham
- The Angeles Clinic & Research Institute
- University of Chicago
- Midwest Cancer Research Group
- Oregon Health & Science University
- The Sarah Cannon Cancer Center
- Texas Cancer Associates
- M.D. Anderson Cancer Center
- University of Texas Health Science Center at San Antonio
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00035867
Brief Title
Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Official Title
Phase 1-2a Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Telik
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
TLK199 HCl Liposomes for Injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The Angeles Clinic & Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Midwest Cancer Research Group
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Cancer Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19439093
Citation
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.
Results Reference
derived
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Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
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