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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

B-cell Chronic Lymphocytic Leukemia

Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 p...

Detailed Description

PRIMARY OBJECTIVES: 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. I...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    March 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2010

    Estimated Enrollment :

    89 Patients enrolled

    Trial Details

    Trial ID

    NCT00290472

    Start Date

    March 1 2004

    End Date

    April 1 2010

    Last Update

    May 23 2014

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    University of Chicago

    Chicago, Illinois, United States, 60637

    2

    Decatur Memorial Hospital

    Decatur, Illinois, United States, 62526

    3

    Evanston Hospital CCOP

    Evanston, Illinois, United States, 60201

    4

    Ingalls Memorial Hospital

    Harvey, Illinois, United States, 60426