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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkins Lymphoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete response rate

Principal Investigator

John D. Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LYM 27

NCT ID:

NCT00193505

Start Date:

October 2003

Completion Date:

August 2005

Related Keywords:

  • Non-Hodgkins Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location
Tennessee Oncology, PLLC Clarksville, Tennessee  37043