Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

Study Overview
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Brief Summary
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In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Detailed Description
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Upon determination of eligibility, patients will receive: Ifosfamide + Carboplatin + Etoposide + Rituximab Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Official Title
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Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma

Conditions
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Non-Hodgkins Lymphoma

Intervention / Treatment
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* Drug: Ifosfamide
* Drug: Carboplatin
* Drug: Etoposide
* Drug: Rituximab
* Drug: 90Y Zevalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be included in this study, you must meet the following criteria: Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma Persistent lymphoma after one or two previous chemotherapy regimens Patients should not be considered candidates for high-dose chemotherapy Ability to perform activities of daily living with assistance Measurable or evaluable disease Age > 18 years Adequate bone marrow, liver and kidney function Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Patients with impaired bone marrow reserve Female patients who are pregnant or lactating Serious active infection at the time of treatment Any other serious underlying condition Brain or meningeal) with lymphoma HIV or AIDS-related lymphoma Received external beam radiation therapy to > 25% of active bone marrow. History of other cancers, either active or treated Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ifosfamide|nan|
|Drug: Carboplatin|nan|
|Drug: Etoposide|nan|
|Drug: Rituximab|nan|
|Drug: 90Y Zevalin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  |  | 
| overall survival |  |  |