everolimus in treating older patients with mantle cell lymphoma previously treated with first-line or second-line chemotherapy

Conditions: Lymphoma

Summary: rationale: everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. purpose: this phase ii trial is studying how well everolimus works in treating older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.

objectives: primary * determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy. secondary * determine the toxicity and feasibility of treatment with this drug. * determine the efficacy of this drug in these patients. * compare the duration of remission after first- vs second-line chemotherapy. * determine the rate of objective remission. outline: this is a multicenter study. patients receive oral everolimus once daily in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed periodically for 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of mantle cell lymphoma * stable disease after first- or second-line chemotherapy * no uncontrolled cerebral or leptomeningeal disease patient characteristics: * who performance status 0-2 * life expectancy ≥ 3 months * age ≥ 60 years or patients ≥ 40 and \< 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation * anc ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * hemoglobin \> 9 g/dl * serum creatinine ≤ 1.5 times upper limit of normal (uln) * sgpt and sgot ≤ 3 times uln * bilirubin ≤ 1.5 times uln * no other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer * no other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness) * no known hiv infection * no gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis) * no coagulation or bleeding diatheses * not pregnant or nursing * fertile patients must use effective contraception * patients must have complied with their previous drug prescription prior concurrent therapy: * see disease characteristics * see patient characteristics * recovered from all prior therapy * at least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy * more than 4 weeks since prior experimental medication * no chronic therapy with systemic steroids or other immunosuppressants except rituximab * no prior organ transplantation * no therapy with vitamin k antagonist, except low-dose coumarin * no prior mtor inhibitors

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