Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically or cytologically confirmed relapsed or chemotherapy/immunotherapy-resistant mantle cell lymphoma

  • No more than 3 lines of prior systemic treatment
• At least one measurable lesion ≥ 15 mm in its greatest transverse diameter by CT scan

Exclusion criteria:

• Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningosis)
• Newly diagnosed mantle cell lymphoma
• Patients suitable for intensive treatment (e.g., hyperfractionated cyclophosphamide, vincristine, doxorubicin hydrochloride and dexamethasone with high-dose methotrexate and cytarabine [HyperCVAD])

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status ≤ 2
• Creatinine clearance ≥ 30mL/min
• Bilirubin ≤ 2 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2 times ULN
• AST and ALT ≤ 2 times ULN
• Neutrophils ≥ 1,500/mm³ (≥ 1,000/mm³ with marrow infiltration)
• Thrombocytes ≥ 100,000/mm³ (≥ 75,000/mm³ in case of bone marrow infiltration)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after study participation

Exclusion criteria:

• Prior or concurrent hematological malignancies

  • Patients with prior solid organ tumors that required no treatment over the last 5 years and are currently free of disease are eligible

• Cardiovascular disease including any of the following:

  • NYHA class III or IV congestive heart failure
  • Unstable angina pectoris
  • Significant arrhythmia or arrhythmia requiring chronic treatment
  • Myocardial infarction in the last 3 months

• Serious underlying medical condition which could impair the ability of the patient to participate in the trial including any of the following:

  • Uncontrolled diabetes mellitus
  • Gastric ulcers
  • Active autoimmune disease
  • Ongoing infection (e.g., HIV or hepatitis)

PRIOR CONCURRENT THERAPY:

Exclusion criteria:

• Prior radiation where the indicator lesion(s) are in the irradiated field
• Prior organ transplantation
• Participation in another clinical trial within 30 days prior to study entry
• Concurrent anticancer drugs/treatments or experimental medications
• Other concurrent investigational therapy
• Other concurrent chemotherapy, immunotherapy, or radiotherapy (including palliative radiotherapy)