TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer

Lung Cancer Clinical Trial

Official title: Phase I/II Clinical Trial Combining TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer

Status Terminated

Clinical Trial Summary

The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-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 DOTAP:Chol-TUSC2 and erlotinib hydrochloride can help to control NSCLC.

The safety of this drug combination will also be studied in both phases.

DOTAP:Chol-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.

Clinical Trial 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 DOTAP:Chol-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 DOTAP:Chol-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 DOTAP:Chol-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.

DOTAP:Chol-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 tablet(s), you should only re-take the dose if the tablet(s) 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 DOTAP:Chol-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 PET/CT 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 DOTAP:Chol-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, DOTAP:Chol-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. ;

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT01455389
• Study type: Interventional
• Source: Genprex, Inc.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: February 2014
• Completion date: September 28, 2020