This phase 2 trial will investigate the effectiveness of genetically-engineered cell treatment (GECT) in advanced cancer.
The main outcome will be the response to treatment. This trial is recruiting at the National Cancer Institute, Maryland, US.
The details
There are limited treatment options for advanced cancer. One experimental treatment involves genetically-engineered cell treatment (GECT). In this treatment, white blood cells (WBCs) are filtered out of the patients' blood. A virus is used to make the WBCs more effective at targeting tumor cells. The GECT cells are re-injected into the patients to kill tumor cells.
This trial will investigate the effectiveness of GECT in advanced cancer. The main outcome will be the response rate.
Who are they looking for?
This trial will recruit 210 patients with advanced tumor, including breast cancer. Patients must have not responded to 2 previous treatments. Patients must have adequate blood cell counts, liver and kidney function tests. Patients must not be pregnant and birth control must be used by all participants during and 4 months after the trial.
Patients on steroid therapy and those involved in another clinical trial cannot take part in the trial. Patients must not have hepatitis B or C or HIV. Systemic infection or blood clotting disorders are excluded from the trial. Other exclusion criteria are heart disease, immunodeficiency disorders or lung dysfunction.
How will it work
All patients will undergo GECT. The study has 7 stages. At the start of the trial, patients will undergo a procedure to filter WBCs. This will be done through a needle in the arm. Blood is returned through a catheter in the chest. WBCs will be genetically engineered and grown in the lab. After 4-6 weeks, patients will stay in the hospital for 1 week of chemotherapy. This will remove all WBCs from the blood. The GECT WBCs will be re-infused after this. Patients will also take a drug to improve the survival of the WBCs.
The main outcome will be the response rate 6-12 weeks after treatment. Patients may be followed up for up to 2-4 years.
