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Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00083694
First Posted: May 31, 2004
Last Update Posted: July 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Celgene Corporation
Information provided by:
University of Arkansas
  Purpose
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Condition Intervention Phase
Leukemia Drug: Thalidomide Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • To evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Estimated Enrollment: 25
Study Start Date: August 1998
Estimated Study Completion Date: May 2005
Detailed Description:
Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.
  • Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed
  • Serum creatinine < or = 2.5mg/dL
  • Serum bilirubin< or = 2.5mg/dL
  • Negative pregnancy test
  • Age 18 years or older
  • Performance status < or = 3

Exclusion Criteria:

  • Pregnant or lactating women
  • Concurrent treatment with cytotoxic chemotherapy, or radiation
  • History of seizures, neurotoxicity, or active CNS disease
  • Serious infections not controlled by antibiotics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083694


Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Celgene Corporation
Investigators
Principal Investigator: Barthel Barlogie, M.D., Ph.D. UAMS
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00083694     History of Changes
Other Study ID Numbers: UARK 98-032
First Submitted: May 27, 2004
First Posted: May 31, 2004
Last Update Posted: July 2, 2010
Last Verified: July 2010

Keywords provided by University of Arkansas:
Leukemia
Thalidomide
relapsed

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents