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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014