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.

Condition	Treatment or Intervention	Phase
Waldenstrom's Macroglobulinemia adult non-Hodgkin's lymphoma	Drug: rituximab  Drug: vinorelbine  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: monoclonal antibody therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of B-cell non-Hodgkin's lymphoma
• Relapsed after high dose chemotherapy and autologous peripheral blood stem cell transplantation
• Not refractory to prior vinorelbine
• No prior myelodysplastic syndrome
• No uncontrolled CNS disease

PATIENT CHARACTERISTICS: Age:

• Over 18

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1000/mm^3
• Platelet count greater than 50,000/mm^3

Hepatic:

• Bilirubin no greater than 2 mg/dL (unless due to tumor involvement)
• ALT/AST no greater than 3 times upper limit of normal (unless due to tumor involvement)

Renal:

• Creatinine no greater than 2 mg/dL (unless due to tumor involvement)

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 12 months after study therapy
• No active serious infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

• See Disease Characteristics
• Prior rituximab allowed

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Study chairs or principal investigators

Christos E. Emmanouilides, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067163; UCLA-9903029; NCI-G99-1545
Record last reviewed:  November 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003963
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08