Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Miami
OBJECTIVES: Primary * To evaluate failure-free survival of patients with newly diagnosed peripheral T-cell non-Hodgkin lymphoma treated with cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone (CHOP), and denileukin diftitox (Ontak®) alternating with high-dose methotrexate, leucovorin calcium, cytarabine, and Ontak® (CHOP-MONTAK regimen). Secondary * To determine the response rate (CR, CRu, and PR) in these patients. * To determine the overall survival of these patients. * To determine the toxicity profile of this regimen. * To correlate response with CD25 expression in these patients. OUTLINE: * Courses 1, 3, and 5: Patients receive cyclophosphamide IV over 30 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1; oral prednisone once daily on days 1-5; and denileukin diftitox IV over 60 minutes on days 1 and 2. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. * Courses 2, 4, and 6: Patients receive high-dose methotrexate (MTX) IV over 24 hours on day 1; cytarabine IV over 2 hours every 12 hours on days 2 and 3; and leucovorin calcium IV over 15 minutes every 6 hours for 8 doses beginning 12 hours after the last dose of each MTX infusion. Patients also receive denileukin diftitox IV over 60 minutes for 2 doses once MTX blood levels have cleared. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Samples are analyzed for CD25-positive or -negative expression and response rate via flow cytometry. After completion of study treatment, patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
