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Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 27, 2003
Last Update Posted: June 28, 2010
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.
National Cancer Institute (NCI)
Information provided by:
University of Nebraska
January 6, 2001
January 27, 2003
June 28, 2010
September 2000
March 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00007865 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.


  • Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in combination with rituximab.
  • Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients.

OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.

Phase 2
Primary Purpose: Treatment
  • Biological: rituximab
  • Drug: carboplatin
  • Drug: etoposide
  • Drug: ifosfamide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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April 2008
March 2004   (Final data collection date for primary outcome measure)


  • Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma

    • CD20 positive
  • Bidimensionally measurable or evaluable disease
  • No myelodysplastic syndrome or chronic myeloid leukemia



  • 19 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • WBC at least 3,000/mm3
  • Granulocyte count at least 1,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 mg/dL


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
  • No active serious infection
  • No other concurrent serious medical condition that would preclude study


Biologic therapy:

  • No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma


  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids except transient administration as antiemetic
  • Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)


  • No concurrent radiotherapy


  • Not specified


  • No other concurrent investigational therapy
  • No other concurrent antitumor agents
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA036727 ( U.S. NIH Grant/Contract )
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Julie M. Vose, Pricipal Investigator, Unversity of Nebraka Medical Center
University of Nebraska
National Cancer Institute (NCI)
Study Chair: Julie M. Vose, MD University of Nebraska
University of Nebraska
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP