The Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib is recruiting patients who are undergoing resection of lung and esophageal cancers, thymic neoplasms, and malignant pleural mesothelioma. The objective of the trial is to evaluate the safety and effectiveness of tumor cell vaccines when combined with Cyclophosphamide and Celecoxib in patients with cancers that involve the chest.
The study, last updated ClinicalTrials.gov on June 16, 2010 has an estimated enrollment of 25. The study began in May, 2010 and is estimated to finish in May 2017.
Mesothelioma disease is a type of cancer that occurs in the lining of the chest or abdomen. Individuals exposed to asbestos particles are likely to develop the disease. Mesothelioma is normally treated with surgery, radiation, chemotherapy or a combination of the three. Mesothelioma prognosis is often grim as there is currently no cure for the disease and patients are diagnosed with short life expectancies.
Both men and women ages 18 and older are eligible to participate in the study as long as there is informed written consent. Patients must have resectable primary small cell or non-small cell lung cancer, esophageal cancer, thymoma, thymic carcinoma, or pleural mesothelioma.
Patients must be evaluated within 12 weeks following surgery or six weeks following adjuvant therapy. Recruits with intracranial metastases who have been treated by surgery or radiation therapy may be eligible provided there is no evidence of active disease and no requirement for anticonvulsant therapy or steroids following treatment.
Participants must have an ECOG performance status of 0-2, an adequate bone marrow reserve and hepatic and renal function. Patients must test negative for HIV and HepBsAg and must be aware of the neoplastic nature of their illnesses, the experimental nature of this therapy, alternative treatments and possible risks associated with the study. Patients must be willing to practice birth control during the study and for four months following the trial.
Patients will be excluded from the study if they are initially rendered NED by combined modality therapy but exhibit disease progression prior to initiation of vaccination.
Recruits who have received 2 or more systemic cytotoxic treatment regimens for thoracic malignancy will be excluded, as will those requiring corticosteroids (other than inhaled). Patients with a life expectancy of less than 12 months will be excluded, as will those who require anticoagulation. Individuals with uncontrolled hypertension, unstable coronary disease, unstable angina, decompensated CHF or myocardial infarction within 6 months of the study cannot participate. Patients with pulmonary function abnormalities will be excluded, as well as pregnant and/or lactating women.
For additional information, please contact the NCI Referral Office: 1-888-NCI-1937 and ncicssc@mail.nih.gov. Additional information can be found on the NIH Clinical Center web page: http://clinicalstudies.info.nih.gov/detail/A_2010-C-0138.html. Please refer to this study by its ClinicalTrials.gov identifier: NCT01143545.
Mesothelioma.com encourages patients with mesothelioma cancer to speak with their oncologist about the potential to enroll in a clinical trial.
