Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma
This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 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 Y 90 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.
Contiguous Stage II Adult Diffuse Large Cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Splenic Marginal Zone Lymphoma
Stage I Adult Diffuse Large Cell Lymphoma
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Radiation: indium In 111 ibritumomab tiuxetan
Radiation: radiation therapy
Procedure: positron emission tomography
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Complete response rate (CR/CRu) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- Functional CR rate [ Time Frame: From the documented beginning of response to time of relapse, assessed up to 10 years ] [ Designated as safety issue: No ]
- Time to treatment failure (TTF) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Estimated by Kaplan-Meier method.
- Overall survival (OS) [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]Estimated by Kaplan-Meier method.
- Duration of response [ Time Frame: From the documented beginning of response (CR, CRu or PR) to the time of relapse, assessed up to 10 years ] [ Designated as safety issue: No ]Estimated by Kaplan-Meier method.
- Toxicity as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2004|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Experimental: Treatment (rituximab, chemotherapy, radiotherapy)
See Detailed Description.
Other Names:Drug: prednisone
Other Names:Drug: cyclophosphamide
Other Names:Drug: doxorubicin hydrochloride
Other Names:Drug: vincristine sulfate
Other Names:Radiation: indium In 111 ibritumomab tiuxetan
Other Name: IDEC-In2B8Radiation: radiation therapy
Other Names:Procedure: positron emission tomography
Undergo PET scans
I. To evaluate the complete response rate (CR) and functional CR rate (CR or Cru/PR and PET negative) 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 RCHOP followed by 90Y -Zevalin™.
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 90Y -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.
I. To evaluate PET scans pre -and post - R-CHOP/Zevalin™ therapy.
Monoclonal antibody (MOAB) therapy/chemotherapy: 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.
MOAB therapy/radioimmunotherapy: Beginning no more than 9 weeks after the last course of MOAB therapy and chemotherapy, 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 Y 90 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088881
|United States, Massachusetts|
|Eastern Cooperative Oncology Group|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Thomas Witzig||Eastern Cooperative Oncology Group|