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

NCT ID: NCT00193505

Last Updated: 2011-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-08-31

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.

Conditions

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Non-Hodgkins Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ifosfamide

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Rituximab

Intervention Type DRUG

90Y Zevalin

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Sarah Cannon Research Institute

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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106-P092

Identifier Type: -

Identifier Source: secondary_id

SCRI LYM 27

Identifier Type: -

Identifier Source: org_study_id

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