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Heparin Injection |
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Clinical Trial: Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome
This study is currently recruiting patients.
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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
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
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
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
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
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
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
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
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
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
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
Resources
- Heparin Injection (Drug Digest)
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