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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab
* Drug: carboplatin
* Drug: etoposide
* Drug: ifosfamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: rituximab|nan|
|Drug: carboplatin|nan|
|Drug: etoposide|nan|
|Drug: ifosfamide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma