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CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
This study has been suspended.
Sponsors and Collaborators: University of Chicago
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00084474
  Purpose

RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: 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 Intervention Phase
Leukemia
Lymphoma
Drug: temsirolimus
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: CCI 779
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of CCI-779 in B-Cell Lymphoma and CLL

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective overall response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 106
Study Start Date: March 2004
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the toxicity and safety of this drug in these patients.
  • Correlate the degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in patients treated with this drug.
  • Correlate CCI-779 induced inactivation of mTOR with response in these patients.

OUTLINE: This is a multicenter study. 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.

PROJECTED ACCRUAL: A total of 47-106 patients (13-32 for the aggressive lymphoma stratum and 17-37 each for the other 2 strata) will be accrued for this study within 21-24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
  • 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
  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 50, 000/mm^3 (> 20,000/mm^3 for patients with thrombocytopenia due to bone marrow involvement)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • 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
  • Fasting cholesterol ≤ 350 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No concurrent prophylactic hematopoietic colony-stimulating factors
  • No concurrent pegfilgrastim

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00084474

Locations
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62701
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615-7828
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46885-5099
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Michigan
Oncology Care Associates, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Missouri
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Sonali M. Smith, MD University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000365314, UCCRC-12983A, NCI-6199
Study First Received: June 10, 2004
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00084474  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent adult lymphoblastic lymphoma
Waldenstrom macroglobulinemia
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Leukemia, Lymphoid
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Lymphoma, large-cell, immunoblastic
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Waldenstrom macroglobulinemia
Lymphoma
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoblastic lymphoma
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Burkitt Lymphoma
B-cell lymphomas
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009