SS1P and Pentostatin Plus Cyclophosphamide for Mesothelioma
Status:
Completed
Trial end date:
2017-08-07
Target enrollment:
Participant gender:
Summary
Background:
- 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.
Objectives:
- To study the effectiveness of SS1P plus two drugs that suppress the immune system to treat
malignant mesothelioma.
Eligibility:
- Individuals at least 18 years of age who have malignant mesothelioma in the chest or
abdomen.
Design:
- 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.