Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00023881|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 10, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: bortezomib||Phase 2|
- Determine the efficacy of bortezomib, in terms of response rate, duration of response, and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase.
- Assess the toxicity of this drug in these patients.
OUTLINE: Patients receive bortezomib intravenous (IV) over 3-5 seconds twice weekly on weeks 1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of a Proteasome Inhibitor, PS-341 (NSC 681239) in Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
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): NCT00023881
|United States, Texas|
|MD Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Jorge Cortes, MD||M.D. Anderson Cancer Center|