Phase I Study of Sequential Depsipeptide/Flavopiridol Infusion in Patients With Malignancies Involving Lungs, Esophagus, or Pleura
Protocol # 05-C-0010
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the study outline?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
This trial is being done because previous animal and laboratory studies show that these medicines have reduced the growth of different types of tumor cells, and the initial studies in humans found that these medicines can be given safely. This trial is to test the safety of two experimental medications given together as well as testing the effects of this drug combination on the patients' cancer. Based on our laboratory studies, we think if we give these two drugs together, they will work better at shrinking cancers than either one given alone.
Who is eligible for this trial? (PDQ)
- 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
What types of drugs or therapies are being used?
The two drugs we use are Depsipeptide (DP) and Flavopiridol (FLA), which are experimental cancer agents directed at killing cancer cells during specific stages of the cancer's cell cycle. Each agent is targeted at certain molecular steps in the cell cycle. Depsipeptide (DP) is an experimental medicine that is being studied for its ability to kill cancer cells or prevent the growth of new cancer cells. Flavopiridol (FLA) is an experimental drug that has been given to patients with a variety of cancers, including breast, lung, and head and neck.
What is the study outline? (PDQ)
- 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
What is the frequency and duration of the visits?
Participants will be treated as an inpatient at the National Institutes of Health in Bethesda, Md. Participants will be admitted to the hospital for about 6 days of treatment and will then have a 2-week break before returning for another treatment. Participants will come back every 3 weeks for a total of four inpatient treatments, which will be over the span of 12 weeks. During the weeks when participants are home, they will be required to have outpatient blood work drawn twice a week, with the results faxed to NIH. Participants will possibly be required to have at least two biopsies of their tumor, one pre- and one post-treatment. At the end of the 12 weeks, participants return to NIH for repeat scans and a clinic evaluation to determine response to the treatment.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. David S. Schrump graduated from the University of Connecticut School of Medicine and completed his general surgery residency at the University of Chicago as well as a 3-year research fellowship in human cancer immunology at Memorial Sloan-Kettering Cancer Center. Following completion of his thoracic surgery residency at the University of Michigan in 1993, Dr. Schrump was appointed to the cardiothoracic surgery faculty at M. D. Anderson Cancer Center. In 1997, he was appointed Head of Thoracic Oncology, Surgery Branch, NCI. He received NIH tenure in 2006. His clinical interests include surgical management of complex thoracic malignancies, and his translational research efforts are focused on epigenetic mechanisms of gene expression in thoracic malignancies and the utilization of chromatin remodeling agents for the treatment of these neoplasms.
Where is this trial taking place?
Mark O. Hatfield Clinical Research Center
National Institutes of Health
NCI Thoracic Oncology
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
David Schrump, M.D.
Principle Investigator
Phone: 301-496-2128
Fax: 301-451-6934
David_Schrump@nih.gov
Referrals:
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
Where can additional information be found?
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