Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059605
Status:
COMPLETED
Last Update Posted:
2012-02-23
First Post:
2003-04-29
Brief Title:
Phase I Study of IV DOTAP Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study Of Intravenous DOTAPCholesterol-Fus1 Liposome Complex DOTAPChol-fus1 In Patients With Advanced Non-Small Cell Lung Cancer NSCLC Previously Treated With Chemotherapy
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to find out the highest safe dose of DOTAPChol-fus1 that can be given to participants in the treatment of non-small cell lung cancer NSCLC or small cell lung cancer SCLC This study is an attempt to transfer a gene fus1 into cancer cells using the drug DOTAPCholesterol-fus1 Researchers will also study the side effects of this experimental gene transfer at different doses and will conduct tests to see if there are any effects on tumor size at different doses Experimental transfer of the fus1 gene into humans has never been tried before
Objectives
Assess the toxicity of DOTAPCholesterol-fus1 Liposome Complex DOTAPChol-fus1 administered intravenously
To determine the maximal tolerated dose and recommended phase II dose of DOTAPChol-fus1 administered intravenously
Assess the expression of fus1 following intravenous delivery of DOTAPChol-fus1 in tumor and normal bronchial epithelial cell biopsies
Assess any anti-cancer activity for DOTAPChol-fus1
Objectives
Assess the toxicity of DOTAPCholesterol-fus1 Liposome Complex DOTAPChol-fus1 administered intravenously
To determine the maximal tolerated dose and recommended phase II dose of DOTAPChol-fus1 administered intravenously
Assess the expression of fus1 following intravenous delivery of DOTAPChol-fus1 in tumor and normal bronchial epithelial cell biopsies
Assess any anti-cancer activity for DOTAPChol-fus1
Detailed Description:
DOTAPChol-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 andor the research staff believes that this may be an error additional tests may be done to confirm or rule out pregnancy The participants tumor will be measured using CT PETCT 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 DOTAPChol-fus1 to try to lessen the potential reactions to the infusion The participant will receive a short infusion of DOTAPChol-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 participants 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 Treatment may continue for participants who continue to benefit from the treatment at the end of the planned 6 treatments if the treating physician the principle investigator and an advisor from the FDA all agree Participants will return to the clinic 3 weeks after their last dose of DOTAPChol-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 treatments 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 DOTAPChol-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 Up to 51 individuals will receive study drug on this study All will be enrolled at M D Anderson
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 andor the research staff believes that this may be an error additional tests may be done to confirm or rule out pregnancy The participants tumor will be measured using CT PETCT 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 DOTAPChol-fus1 to try to lessen the potential reactions to the infusion The participant will receive a short infusion of DOTAPChol-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 participants 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 Treatment may continue for participants who continue to benefit from the treatment at the end of the planned 6 treatments if the treating physician the principle investigator and an advisor from the FDA all agree Participants will return to the clinic 3 weeks after their last dose of DOTAPChol-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 treatments 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 DOTAPChol-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 Up to 51 individuals will receive study drug on this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None