Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083694
First received: May 27, 2004
Last updated: July 1, 2010
Last verified: July 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00083694     History of Changes
Other Study ID Numbers: UARK 98-032
Study First Received: May 27, 2004
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014