Lung Cancer
Phase II Evaluation of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum
NCI-12-C-0151, NCT01624090
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Investigator(s): |
David S. Schrump, M.D. Principal Investigator Phone: 301-496-2128 Fax: 301-451-6934 David_Schrump@nih.gov
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Tricia Kunst, R.N. Research Nurse Phone: 301-451-1233 Fax: 301-451-6933 tricia_kunst@nih.gov
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Key Eligibility Criteria:
- Histologically confirmed primary lung and esophageal carcinomas, thymic neoplasms, malignant pleural mesotheliomas, or chest wall sarcomas, as well as patients with extra-thoracic malignancies metastatic to lungs, esophagus, pleura, or mediastinum
- Measurable inoperable disease
- No more than two prior cytotoxic chemotherapy regimens, excluding non-myeloablative chemotherapy
- Adequate bone marrow reserve, hepatic and renal function, and pulmonary reserve
- ECOG ≤ 2
- No requirement for anticonvulsants, anticoagulants, or steroid therapy
- No uncontrolled hypertension or myocardial infarction within the past 6 months
- Willing to undergo two tumor biopsies and have disease amenable to biopsy via percutaneous approach or other minimally invasive procedures
- Must agree to practice birth control during treatment and two months following treatment
Study Outline:
- Screening physical examination, blood work, and imaging studies to determine eligibility for the study
- The first cycle of treatment is given as an inpatient at the National Institutes of Health Clinical Center unit*
- Mithramycin IV (through a vein) given over about 6 hours every day for 7 days
- This treatment will be repeated every 28 days (1 cycle); two cycles equal one course of therapy, and scans will be repeated after each course of treatment is completed
- Cycles continue as long as the disease does not get worse and there are no serious side effects
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment
* All out-of-town patients will also have subsequent cycles as an inpatient. Local patients may be able to receive subsequent cycles as an outpatient if they are tolerating the drug well.
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/11/12
Updated: 7/24/12