Expired Study
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Houston, Texas 77030


Purpose:

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


Study summary:

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.


Criteria:

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


NCT ID:

NCT00086840


Primary Contact:

Principal Investigator
Francis Giles
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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