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

May 7, 2014 updated by: National Cancer Institute (NCI)

A Phase II Study of CCI-779 in B-cell Lymphoma and CLL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Evanston, Illinois, United States, 60201
        • Evanston Hospital CCOP
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • La Grange, Illinois, United States, 60525
        • Adventist La Grange Memorial Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, United States, 60702
        • Central Illinois Hematology Oncology Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • South Bend, Indiana, United States, 46601
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Oncology Care Associates PLLC
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and The Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Torisel
  • CCI-779
  • cell cycle inhibitor 779

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Overall Response Rate
Time Frame: Up to 6 years
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) 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.
Up to 6 years
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.
Up to 6 years
Overall Survival
Time Frame: Up to 6 years
The overall survival was evaluated using the Kaplan-Meier estimator.
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 13, 2006

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2009-00047 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • N01CM62201 (U.S. NIH Grant/Contract)
  • N01CM62202 (U.S. NIH Grant/Contract)
  • P30CA014599 (U.S. NIH Grant/Contract)
  • CDR0000365314
  • NCI-6199
  • 12983A
  • 6199 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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