Mithramycin for Lung, Esophagus, and Other Chest Cancers
Summary
Background: \- Mithramycin is a drug that was first tested as a cancer therapy in the 1960s. It acted against some forms of cancer, but was never accepted as a treatment. Research suggests that it may be useful against some cancers of the chest, such as lung and esophageal cancer or mesothelioma. Researchers want to see if mithramycin can be used to treat these types of cancer. Objectives: \- To see if mithramycin is safe and effective against different chest cancers. Eligibility: \- Individuals at least 18 years of age who have lung, esophagus, pleura, or mediastinum cancers. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and tumor tissue samples will be used to monitor the cancer before treatment. * Participants will receive mithramycin every day for 7 days, followed by 7 days without treatment. Each 14-day round of treatment is called a cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Participants will continue to take the drug for as long as the side effects are not severe and the tumor responds to treatment.
Timeline
- Start
- 2012-09-06
- Primary completion
- 2019-08-20
- Completion
- 2019-09-27
Outcome
Outcome not reported
Stopped (Enrollment): “Study closed due to low accrual.”
Publications
- Background Centers for Disease Control and Prevention (CDC). Smoking-attributable mortality, years of potential life lost, and productivity losses--United States, 2000-2004. MMWR Morb Mortal Wkly Rep. 2008 Nov 14;57(45):1226-8.
- Background Zhai R, Chen F, Liu G, Su L, Kulke MH, Asomaning K, Lin X, Heist RS, Nishioka NS, Sheu CC, Wain JC, Christiani DC. Interactions among genetic variants in apoptosis pathway genes, reflux symptoms, body mass index, and smoking indicate two distinct etiologic patterns of esophageal adenocarcinoma. J Clin Oncol. 2010 May 10;28(14):2445-51. doi: 10.1200/JCO.2009.26.2790. Epub 2010 Apr 12.
- Background Wright CD, Kucharczuk JC, O'Brien SM, Grab JD, Allen MS; Society of Thoracic Surgeons General Thoracic Surgery Database. Predictors of major morbidity and mortality after esophagectomy for esophageal cancer: a Society of Thoracic Surgeons General Thoracic Surgery Database risk adjustment model. J Thorac Cardiovasc Surg. 2009 Mar;137(3):587-95; discussion 596. doi: 10.1016/j.jtcvs.2008.11.042.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PLICAMYCIN | Small molecule | 50 ug/kg | Intravenous |