Liposomal Vincristine Plus Dexamethasone in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00144963|
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : January 18, 2012
Last Update Posted : April 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: Vincristine Sulfate Liposomes Injection Drug: Dexamethasone||Phase 1 Phase 2|
- Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
- Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II Study of Liposomal Vincristine (VSLI) and Dexamethasone in Relapsed or Refractory Acute Lymphoblastic Leukemia|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
Vincristine Sulfate Liposomes Injection (VSLI)
Drug: Vincristine Sulfate Liposomes Injection
Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days).
Other Name: Marqibo
Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
- MTD of VSLI [ Time Frame: 6 weeks ]Subjects had to receive at least 1 course consisting of 4 weekly infusions of VSLI at the assigned drug dose with a minimum 2 weeks of observation after the last VSLI dose to be included in the evaluation of the MTD.
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): NCT00144963
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Texas|
|University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Deborah Thomas, MD||MD Anderson Cancer Center, Department of Hematology/Oncology|
|Principal Investigator:||Wendy Stock, MD||University of Chicago|
|Principal Investigator:||Leonard Heffner, MD||Emory University|