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Lead
Technical University of Munich
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.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
