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Completed

NCT Number: NCT00007865

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

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.

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Key information

Conditions

Lymphoma Burkitt Lymphoma Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Infections Virus Diseases

Age range

19 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Nebraska Medical Center, Eppley Cancer Center

Omaha, Nebraska, 68198-7680, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

o CD20 positive

  • Bidimensionally measurable or evaluable disease
  • 19 years old and over
  • 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
  • Fertile patients must use effective contraception
  • Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)

Exclusion criteria

  • No myelodysplastic syndrome or chronic myeloid leukemia
  • Not pregnant or nursing/negative pregnancy test
  • 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
  • No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma
  • No other concurrent chemotherapy
  • No concurrent corticosteroids except transient administration as antiemetic
  • No concurrent radiotherapy
  • No other concurrent investigational therapy
  • No other concurrent antitumor agents

Treatment and study plan

Rituximab

Biological

Other names: Rituxan

carboplatin

Drug

Other names: Paraplatin

etoposide

Drug

Other names: Etopophos, Toposar

ifosfamide

Drug

Other names: Ifex

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy

Important dates

Study start
2000
Primary completion
2004
Study completion
2008
First posted
Jan 27, 2003
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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