Non Hodgkin Lymphoma Clinical Trial

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

Summary

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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Full Description

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.

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Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Study ID:

NCT00007865

Recruitment Status:

Completed

Sponsor:

University of Nebraska

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There is 1 Location for this study

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University of Nebraska Medical Center, Eppley Cancer Center
Omaha Nebraska, 68198, United States

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Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Study ID:

NCT00007865

Recruitment Status:

Completed

Sponsor:


University of Nebraska

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