Mithramycin for Children and Adults With Solid Tumors or Ewing Sarcoma

Stopped early · Phase 1/Phase 2

Conditions studied: Ewing Sarcoma, Sarcoma

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 solid tumors, particularly Ewing sarcoma. Researchers want to see if mithramycin can be used to treat solid tumors in children and adults. It will be tested in different groups of people, including those with a type of Ewing sarcoma that contains a chemical called Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1). Objectives: \- To see if mithramycin is safe and effective against solid tumors and Ewing sarcoma in children and adults. Eligibility: * Children and young adults between 1 and 17 years of age with solid tumors that have not responded to standard treatment. * Adults at least 18 years of age with EWS-FLI1 Ewing sarcoma that has not responded to standard treatment. * Children and young adults between 1 and 17 years of age with EWS-FLI1 Ewing sarcoma that has not responded to standard treatment. 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. Individuals with solid brain tumors will not be eligible. * 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.

Key facts

Study ID

NCT01610570

Run by

National Cancer Institute (NCI)

People needed

8

Starts

2012-05-10

Expected to finish

2014-05-21

Last updated by the study team

2018-03-02

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would compromise the patient s ability to tolerate protocol therapy or significantly increase the risk of complications.
• Patients with a history intracranial Ewing sarcoma including cerebral metastases
• Patients with evidence of active bleeding, intratumoral hemorrhage or history of bleeding diatheses
• Patients who are receiving anticoagulants other than prophylactic anticoagulation of venous or arterial access devices, provided that requirements for PT, PTT and fibrinogen are met, as described
• Investigational Drugs: Patients who are currently receiving another investigational drug
• Patients who are concurrently receiving agents, which may increase the risk for mithramycin related toxicities, such as hemorrhage including:
• Thrombolytic agents
• Anti-inflammatory drugs, nonsteroidal (nonsteroidal anti-inflammatory drugs (NSAIDs)) or aspirin or salicylate containing products, which may increase risk of hemorrhage
• Dextran
• Dipyridamole
• Sulfinpyrazone
• Valproic acid
• Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents
• 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 plicamycin (mithramycin)
• Requirement for any of the contraindicated medications: nonsteroidal anti-inflammatory drugs, aspirin, dextran or other iron containing solutions (due to incompatibility), dipyridamole, sulfinpyrazone or valproic acid
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
• Patients receiving concurrently other therapies directed at their cancer.

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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