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
OBJECTIVES:
- 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.
Interventional
Primary Purpose: Treatment
Barbara Gallimore, PhD
Study Chair
Inex Pharmaceuticals
United States: Federal Government
CDR0000068259
NCT00006383
June 2000
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
University of Texas Health Center at Tyler | Tyler, Texas 75708 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |