Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas
- Certain types of lung, esophageal, or thymic cancers and mesotheliomas have specific antigens (protein molecules) on their surfaces. Research studies have shown that giving a vaccine that contains antigens similar to these may cause an immune response, which may keep tumors from growing. Researchers are also interested in determining whether the chemotherapy drug cyclophosphamide and the anti-inflammatory drug celecoxib may help the vaccine work better, particularly in patients with lung cancer.
- To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest.
- Individuals at least 18 years of age who have had surgery for small cell or non-small cell lung cancer, esophageal cancer, thymoma or thymic carcinoma, and malignant pleural mesothelioma.
- Following recovery from surgery, chemotherapy, or radiation, participants will have leukapheresis to collect lymphocytes (white blood cells) for testing.
- Participants will receive celecoxib and cyclophosphamide to take twice a day at home, 7 days before the vaccine.
- Participants will have the vaccine in the clinical center (one or two shots per month for 6 months), and will stay in the clinic for about 4 hours after the vaccine. Participants will keep a diary at home of any side effects from the vaccine, and will continue to take cyclophosphamide and celecoxib.
- One month after the sixth vaccine, participants will provide another blood sample for testing, and if the tests are satisfactory will return to the clinic every 3 months for 2 additional vaccines.
- Participants will return to clinic for follow-up physical examinations, lab tests, and scans every 3 months for 2 years and then every 6 months for up to 3 years.
|Lung Cancer Esophageal Cancer Malignant Pleural Mesothelioma Sarcoma Thymic Carcinoma||Biological: Allogeneic Tumor Cell Vaccine (K562) Drug: Celecoxib Drug: cyclophosphamide||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib as Adjuvant Therapy for Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas|
- Tabulation of toxicity type and grade [ Time Frame: 2 years ]
- To ascertain if K526-GM vaccines induce immunity to CT antigens commonly expressed in thoracic malignancies. [ Time Frame: 2 years ]
- To determine if metronomic oral CP and celecoxib reduce the number, percentage and function of CD4+ CD25+ Fox P3+ regulatory T cells (T reg) in peripheral blood of thoracic oncology patients. [ Time Frame: 2 years ]
|Study Start Date:||May 26, 2010|
|Study Completion Date:||March 19, 2015|
|Primary Completion Date:||February 9, 2015 (Final data collection date for primary outcome measure)|
Allogeneic tumor cell vaccine + chemotherapy
Biological: Allogeneic Tumor Cell Vaccine (K562)
Subcutaneous injection monthly for 6 monthsDrug: Celecoxib
400 g po bidDrug: cyclophosphamide
50 mg po bid
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01143545
|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)|