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

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: October 15, 2007 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Biogen Idec
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193505

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkins Lymphoma	Drug: Ifosfamide Drug: Carboplatin Drug: Etoposide Drug: Rituximab Drug: 90Y Zevalin	Phase II

MedlinePlus related topics: Lymphoma

Drug Information available for: Etoposide Carboplatin Etoposide phosphate Rituximab Ibritumomab tiuxetan Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

complete response rate

Secondary Outcome Measures:

progression-free survival
overall survival

Estimated Enrollment:	40
Study Start Date:	October 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193505

Locations

United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

Sarah Cannon Research Institute

Biogen Idec

Investigators

Principal Investigator:

John D. Hainsworth, MD

Sarah Cannon Research Institute

More Information

No publications provided

Study ID Numbers:	SCRI LYM 27, 106-P092
Study First Received:	September 12, 2005
Last Updated:	October 15, 2007
ClinicalTrials.gov Identifier:	NCT00193505 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Immunoproliferative Disorders
Rituximab
Carboplatin
Etoposide phosphate
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Ifosfamide
B-cell Lymphomas

Mechlorethamine
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Antineoplastic Agents, Phytogenic
Lymphoma
Etoposide
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Carboplatin
Etoposide phosphate
Pharmacologic Actions
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms

Ifosfamide
Therapeutic Uses
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Antineoplastic Agents, Phytogenic
Lymphoma
Etoposide
Isophosphamide mustard

ClinicalTrials.gov processed this record on May 07, 2009