Treating Cancer With Anti-mesothelin Modified Lymphocytes
- A possible new procedure for treating people with advanced cancer uses blood cells known as peripheral blood cells. Once these cells are modified and grown in a laboratory, they can be used to target and destroy cancer cells. Some cells can be modified to target a protein called mesothelin that is found on some types of cancer cells. By blocking mesothelin, it is expected that these cells will help shrink existing tumors. However, it is possible that the cells will not have this effect. Researchers want to try this therapy on people who have advanced cancer that has not responded to standard treatments.
- To test the safety and effectiveness of anti-mesothelin modified cells for advanced cancer.
- Individuals at greater than or equal to 18 years of age and less than or equal to 66 years of age with advanced cancer that involves mesothelin and has not responded to standard treatments.
- Participants will be screened with a physical exam and medical history. They will also have imaging studies before starting treatment. Blood and urine samples will be collected.
- Participants will have leukapheresis to collect peripheral blood cells. These cells will be modified for the treatment.
- Participants will have chemotherapy to prepare the immune system to receive the modified cells. The chemotherapy will take place for 1 week before the cell infusion.
- Participants will receive their modified cells as an infusion. They will also receive interleukin-2 to help boost their immune system response. The interleukin-2 will be given every 8 hours for up to 15 doses.
- Participants will recover from the infusion treatment in the hospital for at least 2 weeks.
- The results of the treatment will be monitored with frequent follow-up blood tests and imaging studies.
Biological: Anti-mesothelin CAR
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Metastatic Cancer Using Lymphodepleting Conditioning Followed by Infusion of Anti-mesothelin Gene Engineered Lymphocytes|
- Determine a safe dose of administration and determine if this approach will result in an objective tumor regression. [ Time Frame: approximately 6 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of anti-mesothelin CAR engineered PBL plus low dose IV aldesleukin.
Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.Biological: Anti-mesothelin CAR
Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of anti-mesothelin CAR engineered PBL. On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).Drug: Cycolphosphamide
Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.Drug: Aldesleukin
Aldesleukin (based on total body weight) 72,000 IU/kg IV over a period of 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583686
|Contact: June Kryk, R.N.||(301) email@example.com|
|Contact: Steven A Rosenberg, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center 866-820-4505 email@example.com|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|