CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Terminated
CT.gov ID
NCT00086840
Collaborator
(none)
60
1
1

Study Details

Study Description

Brief Summary

This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory chronic lymphocytic leukemia. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:
  1. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed chronic lymphocytic leukemia.

OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic lymphocytic leukemia [CLL] vs transformed CLL).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 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 Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia
Study Start Date :
May 1, 2004
Actual Primary Completion Date :
Aug 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (temsirolimus)

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.

Drug: temsirolimus
Given IV
Other Names:
  • CCI-779
  • cell cycle inhibitor 779
  • Torisel
  • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Response (CR or PR) [6 months]

      Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of chronic lymphocytic leukemia (CLL)

    • Relapsed, refractory, or transformed disease

    • Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression

    • Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody

    • Transformed CLL (Richters transformation), must meet both of the following criteria:

    • Histologically confirmed lymphoma

    • Measurable disease

    • No CNS disease

    • Performance status - ECOG 0-2

    • Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease)

    • SGOT and SGPT < 3 times upper limit of normal

    • Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)

    • No symptomatic congestive heart failure

    • No unstable angina pectoris

    • No cardiac arrhythmia

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present

    • No history of 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 concurrent uncontrolled illness

    • See Disease Characteristics

    • No concurrent prophylactic hematopoietic colony-stimulating factors

    • See Disease Characteristics

    • More than 2 weeks since prior cytotoxic chemotherapy and recovered

    • More than 2 weeks since prior radiotherapy and recovered

    • No other concurrent investigational or antitumor agents

    • No other concurrent cytotoxic agents

    • No concurrent combination antiretroviral therapy for HIV-positive patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Francis Giles, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00086840
    Other Study ID Numbers:
    • NCI-2012-02598
    • MDA-2003-0886
    • N01CM17003
    • CDR0000371619
    First Posted:
    Jul 12, 2004
    Last Update Posted:
    Jan 24, 2013
    Last Verified:
    Jan 1, 2013

    Study Results

    No Results Posted as of Jan 24, 2013