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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00007865
First received: January 6, 2001
Last updated: June 25, 2010
Last verified: June 2010

January 6, 2001
June 25, 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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Primary Purpose: Treatment
Lymphoma
  • 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.
 
Completed
Not Provided
April 2008
March 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 19 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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)

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent investigational therapy
  • No other concurrent antitumor agents
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00007865
032-00, P30CA036727, UNMC-032-00, NCI-V00-1635
No
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