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

Sponsor

Jonsson Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00003963

Collaborator

National Cancer Institute (NCI) (NIH), Genentech, Inc. (Industry)

Enrollment

Location

Arm

69.1

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: rituximab Drug: vinorelbine ditartrate	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 1999

Actual Primary Completion Date :

Sep 1, 2003

Actual Study Completion Date :

Feb 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vinorelbine and Rituxan 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.	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. Other Names: 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. Other Names: Vinorelbine

Arm

Intervention/Treatment

Experimental: Vinorelbine and Rituxan

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.

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.

Other Names:

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.

Other Names:

Vinorelbine

Outcome Measures

Primary Outcome Measures

Tolerability and toxicity [13 weeks]
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.

Secondary Outcome Measures

Response rate [13 weeks]
To preliminarily assess the response rates to such a regimen; to assess duration of response.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)