Lung Cancer
Phase I Study of Sequential Depsipeptide/Flavopiridol Infusion in Patients With Malignancies Involving Lungs, Esophagus, or Pleura
NCI-05-C-0010
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Investigator(s): |
David 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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Ana Hancox, R.N. Research Nurse Phone: 301-451-1233 Fax: 301-451-6933 ana_hancox@nih.gov
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Primary Eligibility:
- Histologically or cytologically confirmed advanced malignancy of one of the following types:
- Primary small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC)
- No limited-stage SCLC or operable NSCLC
- Esophageal cancer
- Malignant pleural mesothelioma
- Epithelial thymoma
- Cancer of nonthoracic origin with metastases to the lungs or pleura
- No potentially treatable pulmonary metastases from lymphomas or germ cell tumors
- Disease must be accessible for biopsy (FNA) and must have measurable disease
- No active brain metastases
- No more than two prior chemotherapy regimens
- No history of myocardial infarction within 1 year
- No unstable angina
- No anticoagulants
Treatment Plan:
- Patients are hospitalized for approximately 6 days every third week (1 week of treatment, 2 weeks home) and this is repeated four times over 12 weeks
- Patients receive a 4-hour depsipeptide infusion followed by a 72-hour flavopiridol infusion each week of treatment
- Participants undergo a total of two tumor biopsies, one before treatment and one after treatment
- Participants will be required to get outpatient lab work two times a week
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.
- FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 10/21/08
Updated: 11/14/08