Status:
TERMINATED
CCI-779 in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 way...
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00086840
Start Date
May 1 2004
Last Update
January 24 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030