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Lung Cancer

Phase I Study of Sequential Depsipeptide/Flavopiridol Infusion in Patients With Malignancies Involving Lungs, Esophagus, or Pleura

NCI-05-C-0010                                                                                      Print this page 


Investigator(s):

David Schrump, M.D.
Principal Investigator
Phone: 301-496-2128
Fax: 301-451-6934
David_Schrump@nih.gov

Referral Contact(s):

Tricia Kunst, R.N.
Research Nurse
Phone: 301-451-1233
Fax: 301-451-6933
tricia_kunst@nih.gov

Ana Hancox, R.N.
Research Nurse
Phone: 301-451-1233
Fax: 301-451-6933
ana_hancox@nih.gov

 

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
      • Inoperable disease
    • 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

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