This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

Condition	Intervention	Phase
Lymphoma	Drug: Temsirolimus (CCI-779)	Phase III

Further Study Details: 

Expected Total Enrollment:  177

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis.
• Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance).
• Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following: *Primary disease refractory to at least 2 regimens; *Refractory to at least 1 regimen after first relapse; *Refractory or untreated after second or greater relapse; *Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP, R-CHOP, FCM, R-FCM, ICE, DHAP, and hyper-CVAD.
• Measurable disease in an area of no prior radiation therapy or clear progression in an area that was previously irradiated, with a lymph node or tumor mass ≥ 1.5 cm x 1.5 cm by CT.

Other inclusion criteria may apply.

Exclusion Criteria:

• Subjects who have not received at least one intervening course of treatment following an allogeneic hematopoietic stem cell transplant.
• Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
• Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for > 2 weeks prior to Day 1.)
• Active second malignancy that requires treatment or that would interfere with assessment of response of MCL.
• History of any other primary malignancy with < 5 years documentation of a disease-free state (may be discussed with Wyeth medical monitor: e.g. subjects with a history of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ, which have been successfully treated, are not excluded)

Please refer to this study by ClinicalTrials.gov identifier  NCT00117598

Alabama
      Research Site, Birmingham,  Alabama,  35294,  United States; Not yet recruiting
Arkansas
      Research Site, Little Rock,  Arkansas,  72205,  United States; Not yet recruiting
California
      Research Site, Burbank,  California,  91505,  United States; Recruiting
      Research Site, Los Angeles,  California,  90095,  United States; Not yet recruiting
      Research Site, Fountain Valley,  California,  92708,  United States; Recruiting
Connecticut
      Research Site, New Milford,  Connecticut,  06776,  United States; Recruiting
District of Columbia
      Research Site, Washington,  District of Columbia,  20007,  United States; Not yet recruiting
Florida
      Research Site, Boyton Beach,  Florida,  33435,  United States; Recruiting
      Research Site, Zephyrhills,  Florida,  33542,  United States; Recruiting
      Research Site, New Port Richey,  Florida,  34652,  United States; Recruiting
      Research Site, Orlando,  Florida,  32806,  United States; Not yet recruiting
      Research Site, Tampa,  Florida,  33612,  United States; Not yet recruiting
      Research Site, Boca Raton,  Florida,  33428,  United States; Not yet recruiting
Georgia
      Research Site, Augusta,  Georgia,  30912,  United States; Not yet recruiting
Hawaii
      Research Site, Honolulu,  Hawaii,  96813,  United States; Not yet recruiting
Illinois
      Research Site, Chicago,  Illinois,  60612,  United States; Not yet recruiting
Kansas
      Research Site, Kansas City,  Kansas,  66160,  United States; Not yet recruiting
Michigan
      Research Site, Ann Arbor,  Michigan,  48109,  United States; Not yet recruiting
      Research Site, Detroit,  Michigan,   48202,  United States; Recruiting
      Research Site, Kalamazoo,  Michigan,  49007,  United States; Recruiting
      Research Site, Southfield,  Michigan,  48075,  United States; Not yet recruiting
Nebraska
      Research Site, Omaha,  Nebraska,  68114,  United States; Not yet recruiting
Nevada
      Research Site, Carson City,  Nevada,  89703,  United States; Recruiting
New Jersey
      Research Site, New Brunswick,  New Jersey,  08901,  United States; Not yet recruiting
      Research Site, Morristown,  New Jersey,  07960,  United States; Not yet recruiting
New York
      Research Site, Rochester,  New York,  14642,  United States; Not yet recruiting
      Research Site, Buffalo,  New York,  14263,  United States; Not yet recruiting
      Research Site, New York,  New York,  10011,  United States; Not yet recruiting
      Research Site, New York,  New York,  10032,  United States; Not yet recruiting
      Research Site, Valhalla,  New York,  10595,  United States; Not yet recruiting
      Research Site, New York,  New York,  10021,  United States; Not yet recruiting
      Research Site, Manhasset,  New York,  11030,  United States; Not yet recruiting
      Research Site, New York,  New York,  10029,  United States; Not yet recruiting
      Research Site, New York,  New York,  10016,  United States; Not yet recruiting
North Carolina
      Research Site, Durham,  North Carolina,  27710,  United States; Not yet recruiting
Ohio
      Research Site, Columbus,  Ohio,  43210,  United States; Not yet recruiting
      Research Site, Canton,  Ohio,  44710,  United States; Not yet recruiting
Oregon
      Research Site, Portland,  Oregon,  97227,  United States; Not yet recruiting
Pennsylvania
      Research Site, Pittsburgh,  Pennsylvania,  15224,  United States; Not yet recruiting
      Research Site, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
      Research Site, Upland,  Pennsylvania,  19013,  United States; Not yet recruiting
South Carolina
      Research Site, Greenville,  South Carolina,  29615,  United States; Not yet recruiting
      Research Site, Charleston,  South Carolina,  29406,  United States; Recruiting
Tennessee
      Research Site, Memphis,  Tennessee,  38104,  United States; Not yet recruiting
      Research Site, Knoxville,  Tennessee,  37920,  United States; Not yet recruiting
      Research Site, Nashville,  Tennessee,  37203,  United States; Not yet recruiting
Texas
      Research Site, Dallas,  Texas,  75390,  United States; Not yet recruiting
      Research Site, Irving,  Texas,  75038,  United States; Recruiting
      Research Site, Temple,  Texas,  76508,  United States; Not yet recruiting
      Research Site, Austin,  Texas,  78705,  United States; Recruiting
      Research Site, Houston,  Texas,  77030,  United States; Not yet recruiting
Washington
      Research Site, Seattle,  Washington,  98101,  United States; Not yet recruiting
      Research Site, Seattle,  Washington,  98104,  United States; Not yet recruiting
West Virginia
      Research Site, Huntington,  West Virginia,  25703,  United States; Not yet recruiting
Canada, Alberta
      Research Site, Edmonton,  Alberta,  T6G 1Z5,  Canada; Not yet recruiting
Canada, British Columbia
      Research Site, Vancouver,  British Columbia,  V62 2A5,  Canada; Not yet recruiting
Canada, Ontario
      Research Site, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting
      Research Site, London,  Ontario,  N6A 4E5,  Canada; Not yet recruiting
      Research Site, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
Canada, Quebec
      Research Site, Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
      Research Site, Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
      Research Site, Montreal,  Quebec,  H3A 1A1,  Canada; Not yet recruiting
      Research Site, Greenfield Park,  Quebec,  J4V 2H1,  Canada; Recruiting

Study ID Numbers:  3066K1-305-WW
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 6, 2005
ClinicalTrials.gov Identifier:  NCT00117598
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26