Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00006383|
Recruitment Status : Completed
First Posted : May 30, 2003
Last Update Posted : November 6, 2013
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 liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: liposomal vincristine sulfate||Phase 2|
- Determine the complete and partial tumor responses in patients with aggressive non-Hodgkin's lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection.
- Determine the toxicity of this treatment regimen in these patients.
- Determine the duration of response, time to progression, and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive vincristine sulfate liposomes IV over 1 hour. Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy|
|Study Start Date :||June 2000|
|Actual Study Completion Date :||August 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006383
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1781|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Decatur Memorial Hospital Cancer Care Institute|
|Decatur, Illinois, United States, 62526|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|University of Texas Health Center at Tyler|
|Tyler, Texas, United States, 75708|
|United States, Vermont|
|Vermont Cancer Center|
|Burlington, Vermont, United States, 05401-3498|
|Tom Baker Cancer Center - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Study Chair:||Barbara Gallimore, PhD||Inex Pharmaceuticals|