CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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:
- 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
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:
Other: laboratory biomarker analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
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Diagnosis of chronic lymphocytic leukemia (CLL)
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Relapsed, refractory, or transformed disease
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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
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Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody
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Transformed CLL (Richters transformation), must meet both of the following criteria:
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Histologically confirmed lymphoma
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Measurable disease
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No CNS disease
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Performance status - ECOG 0-2
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Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease)
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SGOT and SGPT < 3 times upper limit of normal
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Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)
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No symptomatic congestive heart failure
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No unstable angina pectoris
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No cardiac arrhythmia
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining disease is present
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No history of allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779
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No ongoing or active infection
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No psychiatric illness or social situation that would preclude study compliance
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No other concurrent uncontrolled illness
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See Disease Characteristics
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No concurrent prophylactic hematopoietic colony-stimulating factors
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See Disease Characteristics
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More than 2 weeks since prior cytotoxic chemotherapy and recovered
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More than 2 weeks since prior radiotherapy and recovered
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No other concurrent investigational or antitumor agents
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No other concurrent cytotoxic agents
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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.- NCI-2012-02598
- MDA-2003-0886
- N01CM17003
- CDR0000371619