Liposomal Vincristine in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
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|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|
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): 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|