Mithramycin for Lung, Esophagus, and Other Chest Cancers

Stopped early · Phase 2

Conditions studied: Lung Cancer, Esophageal Cancer, Mesothelioma, Gastrointestinal Neoplasms, Breast Cancer

In brief

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.

Key facts

Study ID: NCT01624090
Run by: National Cancer Institute (NCI)
People needed: 16
Starts: 2012-09-06
Expected to finish: 2019-09-27
Last updated by the study team: 2019-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Patients with adenosine 5-triphosphate binding cassette subfamily B member 4 (ABCB4), adenosine 5-triphosphate binding cassette subfamily B member 11 (ABCB11), retinal-binding protein (RALBP) or cytochrome P851 (CYP851) genotypes associated with mithramycin-mediated hepatotoxicity.
Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the Principal Investigator (PI) would compromise the patients ability to tolerate protocol therapy or significantly increase the risk of complications
Patients with cerebral metastases
Patients with any of the following pulmonary function abnormalities will be excluded: forced expiratory volume (FEV), < 30% predicted; diffusing capacity for carbon monoxide (DLCO), < 30% predicted (post-bronchodilator); Oxygen saturation greater than 92% on room air. Arterial Blood Gas will be drawn if clinically indicated.
Patients with evidence of active bleeding, intratumoral hemorrhage or history of bleeding diatheses, unless specifically occurring as an isolated incident during reversible chemotherapy induced thrombocytopenia
Patients on therapeutic anticoagulation. Note: prophylactic anticoagulation (i.e. intraluminal heparin) for venous or arterial access devices is allowed
Patients who are concurrently receiving or requiring any of the following agents, which may increase the risk for mithramycin related toxicities, such as hemorrhage:
Thrombolytic agents
Aspirin or salicylate-containing products, which may increase risk of hemorrhage
Dextran
Dipyridamole
Sulfinpyrazone
Valproic acid
Clopidogrel
Lactating or pregnant females (due to risk to fetus or newborn, and lack of testing for excretion in breast milk)
Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) due to potentially increased risk of mithramycin toxicity in this population
Hypersensitivity to mithramycin
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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