Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkin's Lymphoma That Has Relapsed Following Peripheral Stem Cell Transplantation

Jonsson Comprehensive Cancer Center14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma

rituximabBIOLOGICAL

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.

vinorelbine ditartrateDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Tolerability and toxicity

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.

Time frame: 13 weeks

Secondary Outcomes

Response rate

To preliminarily assess the response rates to such a regimen; to assess duration of response.