Lymphoma
Conditions
Keywords
Waldenstrom macroglobulinemia, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALrituximab
Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Week 5-8: Rituxan given every 2 weeks. Week 9-12: Schedule same as week 5-8.
Week 1-4: Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose. Week 5-8: Vinorelbine given weekly x3, with one week off. Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated.
Sponsors
National Cancer Institute (NCI)
Genentech, Inc.
Jonsson Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability and toxicity | 13 weeks | To define the tolerability and toxicity of a combination regimen of rituxan combined with vinorelbine for the treatment of B-cell NHL, relapsing after autologous stem cell transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 13 weeks | To preliminarily assess the response rates to such a regimen; to assess duration of response. |
Countries
United States
Outcome results
None listed