Bortezomib in Treating Patients With Chronic Myelogenous Leukemia
|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|
|Primary Completion Date :||March 2005|
|Study Completion Date :||March 2005|
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|