Expired Study
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Omaha, Nebraska 68198


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00007865


Primary Contact:

Study Chair
Julie M. Vose, MD
University of Nebraska


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68198
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 20, 2017

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