Clinical Trials Directory

Trials / Terminated

TerminatedNCT00088881

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma

A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
62 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the complete response rate (CR) and functional CR rate in patients with previously untreated stage I (with at least 1 risk factor) or stage II CD20+ diffuse large cell lymphoma who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin™. SECONDARY OBJECTIVES: I. To evaluate the time to treatment failure, duration of response, and overall survival in these patients who receive therapy with R-CHOP followed by 90-Yttrium -Zevalin™. II. To evaluate the toxicity of this therapy. III. To evaluate the toxicity of adding involved field radiation therapy \> 12 weeks after Zevalin™ for patients with CT+/PET+ residual masses. TERTIARY OBJECTIVES: I. To evaluate PET scans pre -and post - R-CHOP/Zevalin™ therapy. OUTLINE: R-CHOP (rituximab, prednisone, cyclophosphamide, doxorubicin,vincristine): Patients receive oral prednisone once daily on days 1-5. Patients also receive rituximab IV over several hours followed by cyclophosphamide IV, doxorubicin IV, and vincristine IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study. Radioimmunotherapy: Beginning no more than 9 weeks after the reevaluation (or 12 weeks after the last dose of R-CHOP), patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium 90-Yttrium ibritumomab tiuxetan IV over 10 minutes on day 8. Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually for 5 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALrituximabGiven IV
DRUGprednisoneGiven orally
DRUGcyclophosphamideGiven IV
DRUGdoxorubicinGiven IV
DRUGvincristineGiven IV
RADIATIONindium In 111 ibritumomab tiuxetanGiven IV
RADIATIONradiation therapyUndergo radiotherapy
PROCEDUREpositron emission tomographyUndergo PET scans

Timeline

Start date
2004-12-01
Primary completion
2011-03-01
Completion
2011-03-01
First posted
2004-08-05
Last updated
2017-05-25
Results posted
2015-02-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00088881. Inclusion in this directory is not an endorsement.