Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma

Inclusion Criteria:

• Histologically proven diagnosis of relapsed Waldenstrom macroglobulinemia, relapsed mantle cell, follicular lymphoma, relapsed marginal zone lymphoma, or relapsed small lymphocytic lymphoma previously treated with at least one standard regimen and no longer responding to that regimen (phase I)

• Histologically proven diagnosis of symptomatic Waldenstrom macroglobulinemia, either untreated or relapsed, confirmed by the presence of all of the following (phase II):

  • Bone marrow lymphoplasmacytosis with >= 10% lymphoplasmatic cells (measured within 28 days prior to registration) OR aggregates or sheets of one of the following:

    • Lymphocytes
    • Plasma cells
    • Lymphoplasmacytic cells on the bone marrow biopsy
  • Measurable disease defined as a quantitative IgM monoclonal protein of ≥ 1000 mg/dL
  • Cluster of differentiation 20 (CD20)-positive bone marrow or lymph node by immunohistochemistry or flow cytometry
  • Lymph node biopsy must be done =< 28 days prior to registration if used as an eligibility criterion for study entry
  • Serum protein electrophoresis (SPEP) is required to be performed within 28 days prior to registration

• In addition to measurable disease, patients must have symptomatic disease defined by one or more of the following:

  • Laboratory studies defining eligibility (Hgb, platelet count, viscosity) must have been obtained within 28 days prior to registration; if more than one test was obtained, the most recent one will be utilized
  • Hemoglobin =< 11 g/dL
  • Hyperviscosity syndrome or measured viscosity level of >= 4 centipoise
  • NOTE: For these patients it is strongly recommended that they undergo therapeutic plasmapheresis prior to initiation of therapy
  • Platelet count < 100,000/MM^3
  • Symptomatic lymphadenopathy, splenomegaly, or hepatomegaly
  • Constitutional symptoms including fever, night sweats, or unexplained weight loss (at least 10% of body weight in < 6 months)
  • Symptomatic cryoglobulinemia

• Additional requirements for Waldenstrom's macroglobulinemia (WM) patients (Phase I):

  • Patients must have received previous treatment with at least one standard regimen and are no longer responsive to that regimen
  • If last regimen is with rituximab there must have been at least 6 months since last rituximab dose, and if without rituximab there must have been at least 3 months since last regimen

• Additional requirements for WM patients (Phase II):

  • For previously treated patients, no more than 4 prior regimens are allowed
  • If last regimen is with rituximab there must have been at least 6 months since last rituximab dose, and if without rituximab there must have been at least 3 months since last regimen
• Patients must not be receiving concurrent steroids > 10mg prednisone (or equivalent) per day
• Prior irradiation is allowed if >= 28 days prior to registration have elapsed since the date of last treatment

• Fasting serum cholesterol =< 300 mg/dL OR =< 7.75 mmol/L AND fasting triglycerides =< 2.5 x institutional upper limit of normal (ULN), within 28 days prior to registration

  • NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication; patients cannot be enrolled if they do not meet these criteria on or off lipid lowering medication; patients must start lipid lowering medication and cholesterol and triglycerides must be below said levels before study entry
• Patients must not have had prior exposure to mammalian target of rapamycin (m-TOR) inhibitors (sirolimus, temsirolimus, everolimus)
• Women must not be pregnant or breast-feeding due to the fact that the reproductive risk to humans taking temsirolimus is unknown; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must use an accepted and effective method of contraception throughout the study and for 8 weeks following discontinuation of everolimus
• Patients must have no history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in-situ cervical cancer; the patient may also have had other cancer for which the patient was curatively treated with surgery alone and from which the patient has been disease free for >= 5 years
• Platelets >= 75,000mm^3
• Neutrophils >= 1,000mm^3
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x institutional ULN
• Direct bilirubin =< 1.5 mg/dL
• Serum creatinine =< 2.5 mg/dL
• Patients must be tested for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) within 28 days of registration and will not be eligible if found to be positive

• Patients must not have any severe and/or uncontrolled medical condition or other conditions that could affect their participation in the study, including, but not restricted to:

  • Symptomatic congestive heart failure of New York Heart Association class III or IV
  • Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 3 months of start of study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant heart disease
  • Severely impaired lung function as defined as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for Hgb) that is < 50% of the normal predicted value and/or oxygen (O2) saturation < 88% at rest on room air
  • Active (acute or chronic) or uncontrolled severe infections
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
• Patients must not have grade 2 or higher neuropathy
• Patients must not have concurrent use of angiotensin-converting enzyme (ACE) inhibitors (angioedema), and no concurrent use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors