Clinical Trial: Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

This study is currently recruiting patients.

Sponsored by: Telik
Information provided by: Telik

Purpose

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

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

MedlinePlus related topics:  Bone Marrow Diseases

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: 

Expected Total Enrollment:  51

Study start: April 2002

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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:

  • 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

Location and Contact Information


Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
Lynda Leo, R.N.  204-975-9481 
Peter Emanuel, M.D.,  Principal Investigator

California
      Cancer Institute Medical Group, Los Angeles,  California,  90404,  United States; Recruiting
Sandra Binder, R.N.  310-231-2182    sbinder@cimg.org 
Lawrence D. Piro, M.D.,  Principal Investigator

Illinois
      Midwest Cancer Research Group, Skokie,  Illinois,  60077,  United States; Recruiting
Julianne Rodriguez, RN  312-981-5555 
Elaine Ortenberg, RN  312-664-5400 
Stephanie Williams, M.D.,  Principal Investigator

      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
Peggy Green, RN  773-702-0267    mgreen@medicine.bsd.uchicago.edu 
Richard Larson, MD,  Principal Investigator

Oregon
      Oregon Health & Science University, Portland,  Oregon,  97239,  United States; Recruiting
Laura Bradley  503-494-4467    bradlela@ohsu.edu 
Peter T Curtin, MD,  Principal Investigator

Tennessee
      The Sarah Cannon Cancer Center, Nashville,  Tennessee,  37203,  United States; Recruiting
Cindy Phelps, CCRP  615-986-4307    cphelps@tnonc.com 
Howard A Burris, III, MD,  Principal Investigator

Texas
      M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Jackie Fiorentino, RN  713-563-1688 
Stefan Faderl, M.D.,  Principal Investigator

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
Sydney Rodriguez, R.N.  210-617-5300  Ext. 4720    pryor@uthscsa.edu 
Jose L Ochoa-Bayona, M.D.,  Principal Investigator

      Texas Cancer Associates, Dallas,  Texas,  75231,  United States; Recruiting
Susan Guba, MD  214-739-1706    sguba@txcan.com 
Susan Guba, MD,  Principal Investigator

More Information

Study ID Numbers:  TLK199.1001
Record last reviewed:  December 2004
Last Updated:  December 15, 2004
Record first received:  May 6, 2002
ClinicalTrials.gov Identifier:  NCT00035867
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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