Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma|
- Complete response rate at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Partial response rate at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Overall response rate (complete and partial responses) at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Time to disease progression at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3
IVDrug: pegylated liposomal doxorubicin hydrochloride
- Determine the safety, including qualitative and quantitative toxic effects and their duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's lymphoma.
- Determine the efficacy, including overall response rate and durability of objective response, of this regimen in these patients.
- Correlate pretreatment functional, phenotypic, and genotypic characteristics of host immune effector cells with response in patients treated with this regimen.
OUTLINE: This is an open-label, pilot study.
Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Myron S. Czuczman, MD||Roswell Park Cancer Institute|