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

Primary Purpose

Non-Hodgkins Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ifosfamide
Carboplatin
Etoposide
Rituximab
90Y Zevalin
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkins Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tennessee Oncology, PLLC

Outcomes

Primary Outcome Measures

complete response rate

Secondary Outcome Measures

progression-free survival
overall survival

Full Information

First Posted
September 12, 2005
Last Updated
May 2, 2011
Sponsor
SCRI Development Innovations, LLC
Collaborators
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00193505
Brief Title
Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
Official Title
Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
SCRI Development Innovations, LLC
Collaborators
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkins Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Type
Drug
Intervention Name(s)
90Y Zevalin
Primary Outcome Measure Information:
Title
complete response rate
Secondary Outcome Measure Information:
Title
progression-free survival
Title
overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Hainsworth, MD
Organizational Affiliation
SCRI Development Innovations, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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