Lymphoma Clinical Trial
Official title:
A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Combinations of
biological substances in denileukin diftitox may be able to carry cancer-killing substances
directly to non-Hodgkin lymphoma cells. Giving combination chemotherapy together with
denileukin diftitox may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together
with denileukin diftitox works in treating patients with newly diagnosed T-cell non-Hodgkin
lymphoma.
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.
;
Primary Purpose: Treatment
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