Clinical Trials Directory

Trials / Completed

CompletedNCT00290472

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

A Phase II Study of CCI-779 in B-cell Lymphoma and CLL

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
89 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Detailed description

PRIMARY OBJECTIVES: I. Determine the complete and partial response rate in patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779. II. Determine the toxicity and safety of this drug in these patients. III. Correlate the degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in patients treated with this drug. IV. Correlate CCI-779 induced inactivation of mTOR with response in these patients. OUTLINE: Patients are stratified according to disease (aggressive lymphoma \[group A\] vs follicular lymphoma \[group B\] vs small lymphocytic lymphoma or chronic lymphocytic leukemia \[group C\]). Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 8 weeks.

Conditions

Interventions

TypeNameDescription
DRUGtemsirolimus

Timeline

Start date
2004-03-01
Primary completion
2010-04-01
Completion
2010-04-01
First posted
2006-02-13
Last updated
2014-05-23
Results posted
2014-02-11

Locations

13 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00290472. Inclusion in this directory is not an endorsement.