Mithramycin for Lung, Esophagus, and Other Chest Cancers
- 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.
- To see if mithramycin is safe and effective against different chest cancers.
- Individuals at least 18 years of age who have lung, esophagus, pleura, or mediastinum cancers.
- 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 14 days without treatment. Each 28-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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum|
- To assess clinical response rates of mithramycin administered as 6h intravenous infusions in patients with malignancies involving lungs, esophagus, pleura, or mediastinum. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- toxicity will be assessed as per common terminology criteria for adverse event (CTCAE) version 4 [ Time Frame: from time of administration of first dose through 30 days following administrati ] [ Designated as safety issue: Yes ]
- To determine PK and toxicities; to ascertain if mithramycin inhibits cancer stem cell signaling in patients with thoracic malignancies;to evaluate gene expression, DNA methylation and micro-RNA profiles in pre- and post- treatment tumor biopsies... [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01624090
|Contact: Tricia Kunst, R.N.||(301) email@example.com|
|Contact: David S Schrump, M.D.||(301) firstname.lastname@example.org|
|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 NCI/Surgery Branch Recruitment Center 866-820-4505 email@example.com|
|Principal Investigator:||David S Schrump, M.D.||National Cancer Institute (NCI)|