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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01143545 |
Purpose
Background:
- 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.
Objectives:
- To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest.
Eligibility:
- 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.
Design:
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Esophageal Cancer Malignant Pleural Mesothelioma Thymoma Thymic Carcinoma |
Biological: Allogeneic Tumor Cell Vaccine (K562) Drug: Celecoxib Drug: cyclophosphamide |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
-INCLUSION CRITERIA:
Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
EXCLUSION CRITERIA:
Contacts and Locations| Contact: Tricia Kunst, R.N. | (301) 451-1233 | kunstt@mail.nih.gov |
| Contact: David S Schrump, M.D. | (301) 496-2127 | schrumpd@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
| Principal Investigator: | David S Schrump, M.D. | National Cancer Institute (NCI) |
More Information
| Responsible Party: | David S. Schrump, M.D./National Cancer Institute, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT01143545 History of Changes |
| Other Study ID Numbers: | 100138, 10-C-0138 |
| Study First Received: | June 11, 2010 |
| Last Updated: | April 10, 2012 |
| Health Authority: | United States: Federal Government |
|
Metastatic Lung Cancer Cancer Vaccine Immunotherapy Adjuvant Therapy Surgical Intervention |
Lung Cancer Esophageal Cancer Thymic Carcinoma Malignant Pleural Mesothelioma |
|
Neoplasms Carcinoma Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Mesothelioma Thymoma Thymus Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Mesothelial Neoplasms, Complex and Mixed Lymphatic Diseases Cyclophosphamide Celecoxib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |