A Pilot Study of the Efficacy of the Chop-Montak Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
- 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
- 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.
- 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
Maricer Escalon, MD, MS
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|