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 Center

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Biological: rituximab; Drug: vinorelbine ditartrate

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00003963

NCI-G99-1545

CDR0000067163

UCLA-9903029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Vinorelbine and Rituxan

Experimental group

Description:

Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose. Week 5-8: Rituxan given every 2 weeks. 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.

Treatment:

Drug: vinorelbine ditartrate

Biological: rituximab