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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00086840
First received: July 8, 2004
Last updated: January 23, 2013
Last verified: January 2013

July 8, 2004
January 23, 2013
May 2004
August 2005   (final data collection date for primary outcome measure)
Response (CR or PR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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).
Not Provided
Complete list of historical versions of study NCT00086840 on ClinicalTrials.gov Archive Site
Not Provided
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CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia

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

OBJECTIVES:

I. 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Drug: temsirolimus
    Given IV
    Other Names:
    • CCI-779
    • cell cycle inhibitor 779
    • Torisel
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: temsirolimus
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
Not Provided
August 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00086840
NCI-2012-02598, MDA-2003-0886, N01CM17003, CDR0000371619
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Francis Giles M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP