Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkin's Lymphoma That Has Relapsed Following Peripheral Stem Cell Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 1999 |
| End Date: | February 2005 |
Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to stop cancer cells from dividing so they stop growing or die. Combining
monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus
chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that
has relapsed following autologous peripheral stem cell transplantation.
cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to stop cancer cells from dividing so they stop growing or die. Combining
monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus
chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that
has relapsed following autologous peripheral stem cell transplantation.
OBJECTIVES:
- Determine the tolerability and toxicity of rituximab combined with vinorelbine in
patients with relapsed non-Hodgkin's lymphoma following autologous peripheral blood
stem cell transplantation.
- Assess the response rate and duration of response to this regimen in these patients.
OUTLINE: Patients receive rituximab IV weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine
IV on weeks 2-4, 6-8, and 10-12. Patients who achieve partial response may continue on
vinorelbine from week 14 until disease progression.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
- Determine the tolerability and toxicity of rituximab combined with vinorelbine in
patients with relapsed non-Hodgkin's lymphoma following autologous peripheral blood
stem cell transplantation.
- Assess the response rate and duration of response to this regimen in these patients.
OUTLINE: Patients receive rituximab IV weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine
IV on weeks 2-4, 6-8, and 10-12. Patients who achieve partial response may continue on
vinorelbine from week 14 until disease progression.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
Inclusion Criteria:
- Patients with B-cell Lymphoma, relapsing after high dose chemotherapy and autologous
stem cell transplantation or allogeneneic stem cell or bone marrow transplant
- Age > 18 years old
- Adequate hematologic function, as manifested by ANC > 1000/mm3 and platelet count >
40,000/mm3
- PS WHO: < 3
Exclusion Criteria:
- Patients with serum creatinine > 2 mg%, transaminases (ALT, AST) > 3 times upper
normal value, direct bilirubin > 2 mg%, unless they result from tumor involvement
- Pregnant or lactating females
- History of myelodysplastic syndrome
- Uncontrolled CNS disease
- Active serious infection
- History of refractoriness to vinorelbine. However, prior treatment with rituxan is
not an exclusion (synergy may still occur)
We found this trial at
1
site
10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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