combination chemotherapy in treating patients with newly diagnosed mantle cell lymphoma

Conditions: Lymphoma

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed previously untreated nodular or diffuse mantle cell lymphoma or their blastic variant * no cns involvement * not a candidate for stem cell transplantation or refuses one patient characteristics: age: * 16 and over performance status: * zubrod 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,000/mm\^3\* * platelet count greater than 100,000/mm\^3\* note: \* unless lymphoma involvement hepatic: * bilirubin less than 1.5 mg/dl (unless lymphoma involvement) renal: * creatinine less than 2.0 mg/dl (unless lymphoma involvement) cardiovascular: * cardiac ejection fraction at least 50% (for patients over age 40) other: * must be willing to receive blood transfusion * not pregnant or nursing * fertile patients must use effective contraception * hiv negative * no other co-morbid medical or psychiatric illness that would preclude treatment * no prior or concurrent malignancy with poor prognosis (less than 90% probability of survival at 5 years) prior concurrent therapy: biologic therapy * see disease characteristics chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: stage i mantle cell lymphoma contiguous stage ii mantle cell lymphoma noncontiguous stage ii mantle cell lymphoma stage iii mantle cell lymphoma stage iv mantle cell lymphoma