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
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David S. Schrump, M.D.
Tricia Kunst, R.N.
Key Eligibility Criteria:
- Diagnosis of resectable primary small cell or non-small cell lung cancer, esophageal cancer, thymoma, thymic carcinoma, or pleural mesothelioma
- Undergone surgery with no evidence of disease (NED)
- No more than one systemic cytotoxic treatment regimen
- Adequate bone marrow reserve, hepatic and renal function
- ECOG ≤ 2
- No requirement for anticonvulsants, anticoagulations, or steroid therapy
- Must agree to practice birth control during treatment and for 4 months following treatment
- Patients must be evaluated within 16 weeks following completion of standard therapy
- Leukapheresis to collect lymphocytes (white blood cells) for testing (and at Month 7, if responding, as well as Month 13)
- Celecoxib twice a day by mouth, starting 1 full week before getting the vaccine and then continuing twice a day for 6 months. If the patient shows a response, it will be continued over the next 6 months during the additional 2 vaccines
- Vaccine administered in the clinical center (one or two shots per month for 6 months)
- Participants will keep a diary at home of any side effects from the vaccine
- Cyclophosphamide twice every day during Weeks 1 and 3
- 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 the clinic for follow-up physical examinations, lab tests, and scans every 3 months for 1 year and then every 6 months for up to 4 years
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.