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CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290472
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : February 11, 2014
Last Update Posted : May 23, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
B-cell Chronic Lymphocytic Leukemia Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Malignant Neoplasm Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Splenic Marginal Zone Lymphoma Waldenström Macroglobulinemia Drug: temsirolimus Phase 2

Detailed Description:


I. Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779.

II. Determine the toxicity and safety of this drug in these patients. III. Correlate the degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in patients treated with this drug.

IV. Correlate CCI-779 induced inactivation of mTOR with response in these patients.

OUTLINE: Patients are stratified according to disease (aggressive lymphoma [group A] vs follicular lymphoma [group B] vs small lymphocytic lymphoma or chronic lymphocytic leukemia [group C]).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
Study Start Date : March 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: Arm I
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks.
Drug: temsirolimus
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel

Primary Outcome Measures :
  1. Objective Overall Response Rate [ Time Frame: Up to 6 years ]
    The 1999 international response criteria ( as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.

  2. Duration of Response [ Time Frame: Up to 6 years ]
    Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.

  3. Overall Survival [ Time Frame: Up to 6 years ]
    The overall survival was evaluated using the Kaplan-Meier estimator.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including the following subtypes:

    • Aggressive B-cell lymphoma (Group A)

      • Diffuse large B-cell lymphoma
      • Transformed lymphoma
    • Follicular lymphoma (Group B)
    • Small lymphocytic lymphoma

      • Chronic lymphocytic leukemia (CLL) (Group C)
      • Other B-cell small lymphocytic disorders
  • No mantle cell lymphoma
  • No potentially curative treatment options because of lack of response, relapse, or ineligibility
  • Relapsed or refractory disease
  • Patients with refractory disease (i.e., less than a partial response to the last treatment) must have received no more than 3 prior regimens (group A)
  • Patients with sensitive disease (i.e., at least a partial response to the last treatment) must have received no more than 4 prior regimens (group A)
  • Patients who have failed prior autologous transplantation are eligible (group A)

    • No more than 5 prior regimens (groups B and C)
    • The salvage regimen, conditioning regimen, and any maintenance therapy are considered 1 regimen
  • Prior rituximab or alemtuzumab is not considered prior therapy
  • No limitation to the amount of prior radiotherapy
  • No CNS involvement
  • Performance status: ECOG 0-2 OR Karnofsky 60-100%
  • Life expectancy more than 3 months
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix Completed therapy and considered < 30% risk of relapse
  • No other concurrent uncontrolled illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • No concurrent pegfilgrastim
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • More than 4 weeks since prior radiotherapy and recovered
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent unconventional therapies, food, or vitamin supplements containing Hypericum perforatum (St. John's wort)
  • No other concurrent known inducers of CYP3A4
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • Measurable disease*

    • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan [Note: *Only bone marrow or peripheral blood involvement required for CLL and Waldenstrom's macroglobulinemia ]
  • Absolute neutrophil count >= 1,000/mm3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • AST and ALT =< 2.5 times ULN
  • Creatinine =< 1.5 times ULN
  • Fasting cholesterol =< 350 mg/dL
  • Fasting triglycerides =< 400 mg/dL
  • Platelet count >= 50, 000/mm3 (> 20,000/mm3 for patients with thrombocytopenia due to bone marrow involvement)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290472

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Evanston Hospital CCOP
Evanston, Illinois, United States, 60201
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 60702
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
Oncology Care Associates PLLC
Saint Joseph, Michigan, United States, 49085
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Sonali Smith University of Chicago
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00290472    
Obsolete Identifiers: NCT00084474
Other Study ID Numbers: NCI-2009-00047
NCI-2009-00047 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6199 ( Other Identifier: University of Chicago )
6199 ( Other Identifier: CTEP )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA014599 ( U.S. NIH Grant/Contract )
First Posted: February 13, 2006    Key Record Dates
Results First Posted: February 11, 2014
Last Update Posted: May 23, 2014
Last Verified: February 2013
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Immunoblastic
Plasmablastic Lymphoma
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases