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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193505
First Posted: September 19, 2005
Last Update Posted: May 3, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biogen
Information provided by:
SCRI Development Innovations, LLC
  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 2

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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • complete response rate

Secondary Outcome Measures:
  • progression-free survival
  • overall survival

Estimated Enrollment: 40
Study Start Date: October 2003
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193505


Locations
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Biogen
Investigators
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
  More Information

Responsible Party: John Hainsworth, MD, Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193505     History of Changes
Other Study ID Numbers: SCRI LYM 27
106-P092
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Isophosphamide mustard
Carboplatin
Rituximab
Etoposide
Ifosfamide
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents