Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

Study Overview
=================
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.

Official Title
-----------------
Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: everolimus


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: everolimus|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity and feasibility |  |  | 
| Efficacy |  |  | 
| Comparison of duration of remission after first- vs second-line chemotherapy |  |  | 
| Rate of objective remission |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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