Mithramycin for Lung, Esophagus, and Other Chest Cancers
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|ClinicalTrials.gov Identifier: NCT01624090|
Recruitment Status : Recruiting
First Posted : June 20, 2012
Last Update Posted : November 1, 2018
- 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Esophageal Cancer Mesothelioma Gastrointestinal Neoplasms Breast Cancer||Drug: Mithramycin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum|
|Actual Study Start Date :||September 6, 2012|
|Estimated Primary Completion Date :||August 1, 2025|
|Estimated Study Completion Date :||December 31, 2030|
Single agent IV mithramcyin
30 mcg/kg IV over 6 h once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity
- Objective response rate [ Time Frame: Every 8 weeks until disease progression or unacceptable toxicity ]Changes in tumor size and occurrence of metastases.
- Safety [ Time Frame: Until 30 days after last dose of study drug ]List and description of toxicities
- Pharmacokinetics [ Time Frame: 8 weeks (days 1, 2, 4, 7, 8 & 9 of the 1st 2 4 week cycles) ]Drug level in blood
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624090
|Contact: Tricia Kunst, R.N.||(240) firstname.lastname@example.org|
|Contact: David S Schrump, M.D.||(240) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||David S Schrump, M.D.||National Cancer Institute (NCI)|