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

Stopped early · Phase 2

Conditions studied: Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia

In brief

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

Key facts

Study ID

NCT00086840

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2004-05-01

Last updated by the study team

2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.