Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal
Status:
Terminated
Trial end date:
2016-07-21
Target enrollment:
Participant gender:
Summary
Background:
- A tumor cell vaccine is an experimental cancer treatment. Cancer cells are collected from a
patient and then used to develop a vaccine. The vaccine will produce an immune system
response to help destroy other cancer cells in the body. Researchers are studying ways to
improve these tumor cell vaccines. One way is to add an adjuvant. An adjuvant is a substance
that brings about a stronger immune system response. ISCOMATRIX is an adjuvant that has been
used safely in other clinical studies. But it has not been studied with certain tumor cell
vaccines. Researchers want to find out whether a tumor cell vaccine with ISCOMATRIX, given
along with cancer drug treatment, is a safe and effective way to slow or prevent tumor growth
after tumor removal surgery.
Objectives:
- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and
drug therapy after tumor removal surgery.
Eligibility:
- People at least 18 years of age who have had tumor cell vaccines developed from cells taken
from surgically removed tumors.
Design:
- Patients will be screened with a physical examination, medical history, blood and urine
tests, and imaging studies.
- Patients will be treated with cyclophosphamide (once daily) and celecoxib (twice daily)
for 7 days before the first vaccine dose.
- Patients will receive the tumor cell vaccine once a month for 6 months. They will
continue to receive drug therapy throughout the vaccine treatment. Patients will be
monitored with regular blood tests and imaging studies.
- After the first 6 months, patients who have an immune response to the vaccine will
continue treatment with the vaccine and chemotherapy. They will also have regular blood
tests and imaging studies. They will have this treatment for up to 24 months from the
first vaccination or until they no longer have an immune response.
- Participants will have followup visits for up to 5 years after the first vaccination, or
until the tumor returns.