Lymphoma
Conditions
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
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of duration of remission after first- vs second-line chemotherapy | — |
| Rate of objective remission | — |
| Toxicity and feasibility | — |
| Efficacy | — |
Countries
Germany