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Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination (NCT00003963)

National Cancer Institute (NCI)
Genentech, Inc.
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.
  • Biological: rituximab
    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.
    • Rituxan
  • Drug: vinorelbine ditartrate
    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.
    • Vinorelbine
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts 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)
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.

1 locations

United States (1)
  • Jonsson Comprehensive Cancer Center, UCLA
    Los Angeles, California, United States, 90095-1781
Status:
completed
Type:
Interventional
Phase:
Start:
30 April, 1999
Updated:
29 September, 2015
Participants:
14
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