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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00059605 |
Objectives:
Condition | Intervention | Phase |
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Lung Cancer |
Genetic: DOTAP:Chol-fus1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I Study Of Intravenous DOTAP:Cholesterol-Fus1 Liposome Complex (DOTAP:Chol-fus1) In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy |
Estimated Enrollment: | 30 |
Study Start Date: | March 2003 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
DOTAP:Chol-fus1
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Genetic: DOTAP:Chol-fus1
Infusion of DOTAP:Chol-fus1 by vein once every 3 weeks.
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DOTAP:Chol-fus1 is a drug that helps transfer the fus1 gene into cancer cells. It is thought that the absence of the fus1 gene may be involved in the development of lung cancer tumors. The idea is to try to replace this gene in lung cancer cells.
Participants in this study must have advanced lung cancer that has worsened after receiving prior chemotherapy. Before treatment begins, participants will have a physical exam. Blood (about 2 tablespoons) and urine tests will be performed. Women able to have children will have a blood pregnancy test. Please note that it is possible that the tumor could cause a "positive" pregnancy test result, when you are not pregnant. If a pregnancy test comes back positive, and for any reason you and/or the research staff believes that this may be an error, additional tests may be done to confirm or rule out pregnancy. The participant's tumor will be measured using CT, PET/CT or MRI scans. Participants will also have an EKG (heart function test) and a MUGA scan or echocardiogram.
A treatment cycle on this study is 3 weeks. Participants will receive pre-medications of dexamethasone and diphenhydramine prior to the infusion of DOTAP:Chol-fus1 to try to lessen the potential reactions to the infusion. The participant will receive a short infusion of DOTAP:Chol-fus1 by vein once every 3 weeks. Participants will be examined by their doctor before each treatment. In addition, participants will return to the clinic on days 2, 3, and 8 after the first dose to have blood tests done, their vital signs checked, and to look for side effects. After every two treatment cycles or 6 weeks, the participant's tumor will be measured using a CT or MRI scan. Participants can continue to receive treatments until the tumor gets worse, side effects become too severe, or a maximum of 6 treatments have been given. Participants will return to the clinic 3 weeks after their last dose of DOTAP:Chol-fus1 to have their vital signs checked and to look for side effects. After all treatments are finished, participants will be contacted every 3 months for an update on their health and to gather information about any other treatment(s) they have received.
Participants entered at a given dose level will not be able to receive a higher dose while on study. A group of 3 participants will receive DOTAP:Chol-fus1 by vein at each dose level. After treating 3 participants at a given dose level, the participants will be observed for 2 weeks to evaluate the toxicity. The information showing if the participants develop severe side effects, referred to as dose-limiting toxicity (DLT), will be recorded for computing the chance of toxicity. This information will be used to help select the dose level for the next group of participants. The goal is to find the dose level where 10% of participants develop severe side effects (dose-limiting toxicity).
All the participants will be treated in a dose-escalation fashion starting from the lowest level. The next dose level can be moved up if calculation of the side effects shows that a higher dose is needed. However, no skipping of doses is allowed.
This is an investigational study. A total of 30 individuals will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan Jenkins, RN | 713-563-9152 |
United States, Texas | |
University of Texas M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: David J. Stewart, MD | |
Sub-Investigator: Jack Roth, MD |
Principal Investigator: | David J. Stewart, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( David J. Stewart, MD/Professor ) |
Study ID Numbers: | ID00-123 |
Study First Received: | April 29, 2003 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00059605 |
Health Authority: | United States: Food and Drug Administration |
Non-Small Cell Lung Cancer Small Cell Lung Cancer Lung Cancer NSCLC |
SCLC DOTAP:Chol-fus1 gene gene transfer |
Thoracic Neoplasms Carcinoma, Small Cell Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |