Ignite Creation Date:
2024-05-05 @ 11:57 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01455389
Status:
TERMINATED
Last Update Posted:
2022-03-02
First Post:
2011-10-17
Brief Title:
TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer
Sponsor:
Genprex Inc
Organization:
Genprex Inc
Study Overview
Official Title:
Phase III Clinical Trial Combining TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial terminated by sponsor after decision to evaluate combination of quaratusugene ozeplasmid and osimertinib instead of further evaluating quaratusugene ozeplasmid and erlotinib
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of phase 1 of this clinical research study is to find the highest dose of DOTAPChol-TUSC2 that can be safely given in combination with Tarceva erlotinib hydrochloride to patients with NSCLC
The goal of phase 2 of this clinical research study is to learn if the combination of DOTAPChol-TUSC2 and erlotinib hydrochloride can help to control NSCLC
The safety of this drug combination will also be studied in both phases
DOTAPChol-TUSC2 previously FUS1 is a drug that helps transfer a gene called TUSC2 into cancer cells Researchers think that cells without this gene may be involved in the development of lung cancer tumors They want to find out if replacing the gene in these cells may keep the tissue from forming cancer cells
Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor growth and survival This may stop tumors from growing
The goal of phase 2 of this clinical research study is to learn if the combination of DOTAPChol-TUSC2 and erlotinib hydrochloride can help to control NSCLC
The safety of this drug combination will also be studied in both phases
DOTAPChol-TUSC2 previously FUS1 is a drug that helps transfer a gene called TUSC2 into cancer cells Researchers think that cells without this gene may be involved in the development of lung cancer tumors They want to find out if replacing the gene in these cells may keep the tissue from forming cancer cells
Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor growth and survival This may stop tumors from growing
Detailed Description:
Study Groups
If you are found to be eligible to take part in this study you will be assigned to a dose level of DOTAPChol-TUSC2 and erlotinib hydrochloride based on when you join this study Up to 4 dose levels of the study drug combination will be tested Three 3 participants will be enrolled at each dose level The first group of participants will receive the first dose combination level After this dose is given the participants will be watched for 3 weeks to check for any serious side effects at that dose level If any participants in this first group have intolerable side effects 1-2 lower dose combinations of the study drugs may be tested
If no intolerable side effects are seen in the first group the second study group will receive the next planned dose combination If no intolerable side effects are seen in this group the last dose combination will be tested
If you are enrolled in the Phase II portion you will receive the highest study combination dose that was tolerated in the Phase I portion
During the Phase II portion of the study half of the participants will not start receiving erlotinib hydrochloride until Day 8 of Cycle 1 - 1 day Every odd-numbered participant 1 3 5 and so on enrolled in Phase II will receive this delayed schedule for erlotinib hydrochloride NOTE For all participants dosing of erlotinib has been changed to begin on Day 8 of Cycle 1 and then daily
Study Drug Administration
You will receive the drugs dexamethasone and diphenhydramine before each infusion of DOTAPChol-TUSC2 to try to lower the risk of possible allergic reactions to the study drug Dexamethasone will be given by mouth about 24 hours before your dose of DOTAPChol-TUSC2 and by vein about 30 minutes before the dose Diphenhydramine will also be given either by mouth or as an injection about 30 minutes before the dose
DOTAPChol-TUSC2 is given by vein as an infusion over 25-35 minutes on Day 1 of every 3-week study cycle
You will take erlotinib hydrochloride by mouth in tablet form every day you are on study except for first week of Cycle 1 if you were enrolled in the Phase II delayed-schedule group
Erlotinib hydrochloride tablets should be taken at about the same time each day Each erlotinib dose should be taken with about 8 ounces of water and should be taken 1 hour before or 2 hours after meals The whole dose must be taken at one time If you vomit after taking the tablets you should only re-take the dose if the tablets can still be seen and counted
Study Tests
Each study cycle is 3 weeks
On Day 1 of each cycle
Your vital signs blood pressure heart rate temperature and breathing rate will be measured
Urine will be collected for routine tests
You will have a test to measure the level of oxygen in your blood
On Day 1 of Cycle 1 only blood about 4 tablespoons total will be drawn before your first dose of DOTAPChol-TUSC2 and then about 24 hours later - 4 hours for research tests to check your immune system
On Day 2 of each cycle
Blood about 2 teaspoons will be drawn for routine tests and tests to check your immune system
Your vital signs will be recorded and you will be asked about any side effects you may have
On Day 7 of Cycle 1 you will have a liquid tumor biopsy for genetic research tests
On Day 21 of each cycle
You will have a physical exam including measurement of your vital signs
Your medical history will be recorded and you will be asked about any side effects you may be having
Blood about 2 teaspoons and urine will be collected for routine tests
On Day 21 of every other cycle Cycles 2 4 6 and so on you will have either a chest CT or PETCT scan to check the status of the disease Other scans may be performed if your doctor thinks they are needed
PK Testing
If you are in Phase 1 and are one of the first 6 participants to be enrolled on this study blood about 2 teaspoons each time will be drawn for pharmacokinetic PK testing PK testing measures the amount of study drug in the body at different time points PK samples will be drawn during Cycle 1 at the following times
Day 1--before the dose of DOTAPChol-TUSC2 at 15 and 30 minutes after the dose and then 1 3 and 6 hours after the dose
Day 2
Day 4
Day 8
Day 15
Length of Treatment
You may continue taking the study drug for as long as the doctor thinks it is in your best interest You will no longer be able to take the study drug if the disease gets worse intolerable side effects occur or you are unable to follow study directions
Long-Term Follow-up
You will be called by the study staff every 3 months after you stop taking the study drugs The study staff will ask you questions to find out how you are doing and to collect information on any other therapies you have received for cancer The call should take about 15 minutes
This is an investigational study Erlotinib hydrochloride is commercially available and FDA approved for the treatment of non-small-cell lung cancer At this time DOTAPChol-TUSC2 is only being used in research
Up to 57 patients will take part in this study All will be enrolled at MD Anderson as well as additional clinical sites
If you are found to be eligible to take part in this study you will be assigned to a dose level of DOTAPChol-TUSC2 and erlotinib hydrochloride based on when you join this study Up to 4 dose levels of the study drug combination will be tested Three 3 participants will be enrolled at each dose level The first group of participants will receive the first dose combination level After this dose is given the participants will be watched for 3 weeks to check for any serious side effects at that dose level If any participants in this first group have intolerable side effects 1-2 lower dose combinations of the study drugs may be tested
If no intolerable side effects are seen in the first group the second study group will receive the next planned dose combination If no intolerable side effects are seen in this group the last dose combination will be tested
If you are enrolled in the Phase II portion you will receive the highest study combination dose that was tolerated in the Phase I portion
During the Phase II portion of the study half of the participants will not start receiving erlotinib hydrochloride until Day 8 of Cycle 1 - 1 day Every odd-numbered participant 1 3 5 and so on enrolled in Phase II will receive this delayed schedule for erlotinib hydrochloride NOTE For all participants dosing of erlotinib has been changed to begin on Day 8 of Cycle 1 and then daily
Study Drug Administration
You will receive the drugs dexamethasone and diphenhydramine before each infusion of DOTAPChol-TUSC2 to try to lower the risk of possible allergic reactions to the study drug Dexamethasone will be given by mouth about 24 hours before your dose of DOTAPChol-TUSC2 and by vein about 30 minutes before the dose Diphenhydramine will also be given either by mouth or as an injection about 30 minutes before the dose
DOTAPChol-TUSC2 is given by vein as an infusion over 25-35 minutes on Day 1 of every 3-week study cycle
You will take erlotinib hydrochloride by mouth in tablet form every day you are on study except for first week of Cycle 1 if you were enrolled in the Phase II delayed-schedule group
Erlotinib hydrochloride tablets should be taken at about the same time each day Each erlotinib dose should be taken with about 8 ounces of water and should be taken 1 hour before or 2 hours after meals The whole dose must be taken at one time If you vomit after taking the tablets you should only re-take the dose if the tablets can still be seen and counted
Study Tests
Each study cycle is 3 weeks
On Day 1 of each cycle
Your vital signs blood pressure heart rate temperature and breathing rate will be measured
Urine will be collected for routine tests
You will have a test to measure the level of oxygen in your blood
On Day 1 of Cycle 1 only blood about 4 tablespoons total will be drawn before your first dose of DOTAPChol-TUSC2 and then about 24 hours later - 4 hours for research tests to check your immune system
On Day 2 of each cycle
Blood about 2 teaspoons will be drawn for routine tests and tests to check your immune system
Your vital signs will be recorded and you will be asked about any side effects you may have
On Day 7 of Cycle 1 you will have a liquid tumor biopsy for genetic research tests
On Day 21 of each cycle
You will have a physical exam including measurement of your vital signs
Your medical history will be recorded and you will be asked about any side effects you may be having
Blood about 2 teaspoons and urine will be collected for routine tests
On Day 21 of every other cycle Cycles 2 4 6 and so on you will have either a chest CT or PETCT scan to check the status of the disease Other scans may be performed if your doctor thinks they are needed
PK Testing
If you are in Phase 1 and are one of the first 6 participants to be enrolled on this study blood about 2 teaspoons each time will be drawn for pharmacokinetic PK testing PK testing measures the amount of study drug in the body at different time points PK samples will be drawn during Cycle 1 at the following times
Day 1--before the dose of DOTAPChol-TUSC2 at 15 and 30 minutes after the dose and then 1 3 and 6 hours after the dose
Day 2
Day 4
Day 8
Day 15
Length of Treatment
You may continue taking the study drug for as long as the doctor thinks it is in your best interest You will no longer be able to take the study drug if the disease gets worse intolerable side effects occur or you are unable to follow study directions
Long-Term Follow-up
You will be called by the study staff every 3 months after you stop taking the study drugs The study staff will ask you questions to find out how you are doing and to collect information on any other therapies you have received for cancer The call should take about 15 minutes
This is an investigational study Erlotinib hydrochloride is commercially available and FDA approved for the treatment of non-small-cell lung cancer At this time DOTAPChol-TUSC2 is only being used in research
Up to 57 patients will take part in this study All will be enrolled at MD Anderson as well as additional clinical sites
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