flavopiridol in treating patients with previously untreated or relapsed 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. purpose: phase ii trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.

objectives: * assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma. * assess the toxicity of this regimen in this patient population. * determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen. outline: this is a multicenter study. patients receive flavopiridol iv over 1 hour daily for 3 days. treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. patients with a complete response (cr) receive 2 additional courses after documented cr. patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. patients with stable disease receive a maximum of 4 courses. patients are followed at 4 weeks and then every 3 months until relapse or death. projected accrual: a total of 14-30 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy * no documented disease progression while receiving prior chemotherapy * cd20 and cd5 positive * presence of clinically and/or radiologically documented disease * at least 1 site of disease must be bidimensionally measurable * bone lesions not considered bidimensionally measurable * minimum indicator lesions must be: * lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral ct scan or * other nonnodal lesions at least 1 cm x 1 cm by mri, ct scan, or physical exam * no known cns involvement by lymphoma patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute granulocyte count at least 1,500/mm3 * platelet count at least 75,000/mm3 hepatic: * bilirubin no greater than 1.5 times upper limit or normal (uln) * ast no greater than 2.5 times uln renal: * creatinine no greater than 1.5 times uln or * creatinine clearance at least 60 ml/min cardiovascular: * no clinically significant cardiac symptomatology * if history of cardiac disease, cardiac ejection fraction greater than 50% pulmonary: * no clinically significant pulmonary symptomatology * if history of symptomatic pulmonary disease: * fev1, fvc, and tlc greater than 60% predicted * dlco greater than 50% predicted other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * must be accessible for treatment and follow-up (i.e., no geographical limitations) * no uncontrolled bacterial, fungal, or viral infection * no other serious concurrent disease prior concurrent therapy: biologic therapy: * no prior radioactive monoclonal antibody therapy * prior rituximab allowed chemotherapy: * see disease characteristics * no more than 2 prior chemotherapy regimens allowed * same chemotherapy combination given for first line and second line therapy considered 2 regimens * at least 6 weeks since prior chemotherapy * no prior high-dose chemotherapy and stem cell transplantation * no other concurrent cytotoxic chemotherapy endocrine therapy: * no concurrent corticosteroids radiotherapy: * no prior radiotherapy to greater than 25% of functioning bone marrow * at least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered * no concurrent radiotherapy to sole site of measurable disease surgery: * at least 2 weeks since prior major surgery other: * no other concurrent investigational anticancer agents

Keywords: stage i mantle cell lymphoma stage iii mantle cell lymphoma stage iv mantle cell lymphoma recurrent mantle cell lymphoma stage ii mantle cell lymphoma