Tumor Cell Vaccines and ISCOMATRIX With Chemotherapy After Tumor Removal
- 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.
- To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and drug therapy after tumor removal surgery.
- People at least 18 years of age who have had tumor cell vaccines developed from cells taken from surgically removed tumors.
- 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.
|Sarcoma Melanoma Epithelial Malignancies Pleural Malignancy||Biological: Epigenetically Modified Autologous Tumor Drug: Cyclophosphamide Drug: Celecoxib||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||Epigenetically-Modified Autologous Tumor Cell Vaccs and ISCOMATRIX(TM) Adjuvant With Metronomic Oral Cyclophosphamide and Celecoxib in Pts Undergoing Resection of Sarcomas, Melanomas, Germ Cell Tumors, or Epithelial Malignancies Metastatic to Lungs, Pleura or Mediastinum|
- tabulation and grade of observed patient toxicities attributed to the vaccine, and report of the fractions of patients who encounter these toxicities at the various grades [ Time Frame: 5 years ]
- Determine if 5 or greater of the first 20 vaccinated patients undergoing thoracic metastasectomy have successful tumor cell line development [ Time Frame: 2-3 years ]
- Number and characteristics of immunologic responses to a panel of CT antigens in vaccinated patients [ Time Frame: 7 years ]
|Study Start Date:||April 18, 2011|
|Study Completion Date:||July 21, 2016|
|Primary Completion Date:||May 12, 2016 (Final data collection date for primary outcome measure)|
autologous tumor vaccine plus chemotherapy
Biological: Epigenetically Modified Autologous Tumor
5x 10^7 autologous tumor cells emulsified in 0.5 mL ISCOMATRIX adjuvant will be administered IM every 4 weeks for 6 monthsDrug: Cyclophosphamide
50 mg PO BID for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each 4 week treatment cycleDrug: Celecoxib
400 mg PO BID for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each 4 week vaccine cycle.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341496
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||David S Schrump, M.D.||National Cancer Institute (NCI)|