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CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This study has been completed.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00086840
  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 relapsed or refractory 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 Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia

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

Primary Outcome Measures:
  • Treatment activity [ Designated as safety issue: No ]
  • Correlative studies [ Designated as safety issue: No ]

Study Start Date: July 2004
Detailed Description:

OBJECTIVES:

  • 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.

PROJECTED ACCRUAL: A total of 25-60 patients (12-36 patients with relapsed or refractory chronic lymphocytic leukemia [CLL] and 13-24 patients with transformed CLL) will be accrued for this study within 40 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease)
  • SGOT and SGPT < 3 times upper limit of normal

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • See Disease Characteristics
  • More than 2 weeks since prior cytotoxic chemotherapy and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 2 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • No other concurrent investigational or antitumor agents
  • No other concurrent cytotoxic agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086840

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4095
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Francis J. Giles, MD M.D. Anderson Cancer Center
  More Information

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

Study ID Numbers: CDR0000371619, MDA-2003-0886, NCI-6177
Study First Received: July 8, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00086840  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
refractory chronic lymphocytic leukemia
recurrent adult diffuse large cell lymphoma
recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Leukemia, Lymphoid
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Leukemia, B-cell, chronic
Recurrence
Lymphoma, large-cell
Leukemia
Lymphatic Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease

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

ClinicalTrials.gov processed this record on January 15, 2009