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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003963
• Other study ID #: CDR0000067163
• Secondary ID: UCLA-9903029NCI-
• Status: Completed
• Phase: Phase 2
• Start date: May 1999
• Est. completion date: February 2005

Study information

• Verified date: July 2012
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2005
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lymphoma

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Genentech, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 weeks
Secondary	Response rate	To preliminarily assess the response rates to such a regimen; to assess duration of response.	13 weeks