Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma

• Estimate independently assessed Progression Free Survival (PFS) [ Time Frame: every 6 weeks for first 2 assessments ] [ Designated as safety issue: No ]
• Estimate independently assessed Progression Free Survival (PFS) [ Time Frame: then every 8 weeks ] [ Designated as safety issue: No ]

• Estimate Overall survival [ Time Frame: every 3 months from last dose of study drug ] [ Designated as safety issue: No ]
• Estimate objective response rate [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]
• Estimate PFS per investigator [ Time Frame: every 6 weeks for first 2 assessments, then every 8 weeks in first year, every 12 weeks second year ] [ Designated as safety issue: No ]
• Assess safety, including infection and bleeding [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
• Quantify potential of temsirolimus to alter disposition of desipramine, a substrate of CYP2D6 metabolism [ Time Frame: first 2 weeks of study ] [ Designated as safety issue: No ]

• Estimate Overall survival [ Time Frame: every 6 months from last dose of study drug ] [ Designated as safety issue: No ]
• Estimate objective response rate, independently and investigator assessed [ Time Frame: every 6 weeks for first 2 assessments ] [ Designated as safety issue: No ]
• Estimate objective response rate, independently and investigator assessed [ Time Frame: then every 8 weeks ] [ Designated as safety issue: No ]
• Estimate investigator assessed PFS [ Time Frame: every 6 weeks for first 2 assessments ] [ Designated as safety issue: No ]
• Estimate investigator assessed PFS [ Time Frame: then every 8 weeks ] [ Designated as safety issue: No ]
• Assess safety, including adverse events of infection and bleeding [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]
• Quantify potential effect of temsirolimus to alter the disposition of desipramine, a substrate of CYP2D6 metabolism [ Time Frame: first 2 weeks of study ] [ Designated as safety issue: No ]

This study will compare the effectiveness and safety of two different doses of temsirolimus (Torisel).

• Drug: temsirolimus
  175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
  Other Name: Torisel
• Drug: temsirolimus
  75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
  Other Name: Torisel

• Active Comparator: temsirolimus (Torisel) 175mg weekly x 3, then 75mg weekly
  Intervention: Drug: temsirolimus
• Active Comparator: temsirolimus (Torisel) 75mg weekly
  Intervention: Drug: temsirolimus

Inclusion Criteria:

• Have confirmed mantle cell lymphoma diagnosis.
• Have measurable disease.
• Have received at least 2 prior treatment, which may include stem cell transplant.
• Have adequate organ and bone marrow function.
• There are other criteria--please discuss with your doctor.

Exclusion Criteria:

• Had any prior treatment with temsirolimus or mTOR inhibitor.
• Had allogeneic stem cell transplant within last 6 months and on immunosuppressive therapy.
• Has active or untreated brain or central nervous system metastases.
• There are other criteria--please discuss with your doctor.