SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
- Malignant mesothelioma is a form of cancer that develops on the protective lining that covers the body s internal organs. It most often occurs on the lining of the lungs and chest wall or the lining of the abdomen. There is no known cure for malignant mesothelioma, so researchers are searching for new ways to treat it.
- Mesothelin is a protein that is found in mesothelioma and other types of cancer cells. An experimental cancer drug called SS1P is designed to attack cells that have mesothelin while leaving healthy cells alone. Researchers want to test how effective SS1P is when it is given with pentostatin and cyclophosphamide. These drugs help suppress the immune system and may make the SS1P more effective.
- To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat malignant mesothelioma.
- Individuals at least 18 years of age who have malignant mesothelioma in the chest or abdomen.
- Participants will be screened with a physical exam, medical history, and blood tests. They will also have imaging studies.
- The first treatment cycle will last 30 days. Up to three 21-day cycles of treatment will follow.
- In the first cycle, participants will have pentostatin on days 1, 5, and 9. They will have cyclophosphamide on days 1 through 12. They will have SS1P on days 10, 12, and 14.
- On the next three cycles, participants will have pentostatin on day 1.They will have cyclophosphamide on days 1 through 4. They will have SS1P on days 2, 4, and 6.
- Participants will have frequent blood tests and other studies. They will receive all four cycles of treatment as long as there are no severe side effects.
- Participants will have regular followup visits as directed by the study doctors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot/ Phase II Study of Pentostatin Plus Cyclophosphamide Immune Depletion to Decrease Immunogenicity of SS1P in Patients With Mesothelioma|
- Determining safety, tolerability, and feasibility of a conditioning regimen of pentostatin and cyclophosphamide in combination with SS1(dsFv)PE38
- Monitoring antibody formation to SS1(dsFv)PE38 and assessing the impact of the conditioning regimen
- To evaluate the objective tumor response, duration of response and progression-free survival
- To investigate the potential of soluble mesothelin levels to predict any therapeutic response
|Study Start Date:||May 2011|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Raffit Hassan, M.D.||National Cancer Institute (NCI)|