Lymphoma Clinical Trial
Official title:
Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of different regimens of combination
chemotherapy in treating patients with newly diagnosed mantle cell lymphoma.
OBJECTIVES:
- Evaluate the complete response rate and duration of response in patients with newly
diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with
high-dose methotrexate and cytarabine and high-dose cyclophosphamide, dexamethasone,
doxorubicin, and vincristine (HCVAD).
OUTLINE: This is a multicenter study. Patients may receive either regimen A or both regimen A
and regimen B, depending upon response.
- Regimen A: Patients receive methotrexate IV over 24 hours on day 1. Cytarabine is
administered IV over 2 hours every 12 hours on days 2 and 3. Filgrastim (G-CSF) is
administered subcutaneously (SC) daily beginning on day 4 and continuing until blood
counts recover. Treatment repeats every 21 days for up to 8 courses.
- Regimen B: Patients receive cyclophosphamide IV over 3 hours every 12 hours on days 1-3.
Doxorubicin is administered IV over 24 hours on days 4 and 5. Vincristine is
administered IV over 30 minutes on days 4 and 11. Dexamethasone is administered orally
or IV on days 1-4 and 11-14. G-CSF is administered SC beginning on day 6 and continuing
until blood counts recover. Treatment repeats every 21 days for up to 7 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 4 years.
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