Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00290472 |
Primary Objective:
Secondary Objectives:
Condition | Intervention | Phase |
---|---|---|
Lymphoma Leukemia |
Drug: CCI-779 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of CCI-779 in B-Cell Lymphoma and Chronic Lymphocytic Leukemia (CLL) |
Estimated Enrollment: | 101 |
Study Start Date: | May 2005 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CCI-779
|
Drug: CCI-779
25 mg IV Over 30 Minutes
|
CCI-779 is an experimental drug that is designed to interfere with a protein (mTOR) in the cell that plays a part in cell growth and survival. By interfering with this protein, cancer cells may stop growing or die.
Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will be asked questions about your medical history and have a physical exam. You will have your vital signs, weight, and height measured. You will have around 3 tablespoons of blood drawn for routine blood tests. You must have a negative blood pregnancy test (about 1 teaspoon) if you are a woman who is able to have children. You will have a CT (computed tomography) or a MRI (magnetic resonance imaging) scan to check on the size and locations of the cancer. You will also have a sample of bone marrow collected. To collect a bone marrow sample , an area of the hip is numbed with anesthetic and a small amount of bone marrow is withdrawn with a large needle.
If you are found to be eligible to take part in this study, you will receive the drug CCI-779 through a small needle in the vein over about 30 minutes once a week. You will receive a dose of diphenhydramine (Benadryl) by vein about 30 minutes before each dose of CCI-779 to decrease the risk of an allergic reaction to CCI-779. You will not be admitted to the hospital to receive treatment on this study.
During treatment, you will have blood draws (between 2-3 tablespoons) every week for routine tests. Every 4 weeks during treatment, you will be asked questions about your medical history and have a physical exam to check for any side effects. Every 8 weeks, you will have CT or MRI scans to see if your tumor is responding.
You will be taken off study if the disease progresses or intolerable side effects occur.
If you are taken off study for any reason, you will be asked to come back to the clinic for follow-up visits every 8 weeks. These visits will include a physical exam, routine blood tests (about 5-8 teaspoons), and CT scans.
This is an investigational study. CCI-779 is authorized for use in research only. A total of up to 101 patients will take part in this multicenter study. Between 20-40 to will be enrolled at M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Barbara Pro, MD | The University of Texas MD Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Barbara Pro, MD/Associate Professor ) |
Study ID Numbers: | 2004-0612 |
Study First Received: | February 10, 2006 |
Last Updated: | October 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00290472 |
Health Authority: | United States: Institutional Review Board |
Chronic Lymphocytic Leukemia Lymphoma Leukemia |
CCI-779 Temsirolimus Torisel |
Chronic lymphocytic leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia, B-cell, chronic Lymphoma, B-Cell Leukemia Lymphatic Diseases |
Leukemia, Lymphocytic, Chronic, B-Cell B-cell lymphomas Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |