Prospective Evaluation of Epigenetic Alterations in Patients With Thoracic Malignancies
Protocol # 06-C-0014
- 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 protocol is designed to facilitate screening of patients for investigational protocols in the Thoracic Oncology Section, Surgery Branch, NCI, and in doing so, obtain tissue samples to enable evaluation of epigenetic events in primary and metastatic thoracic malignancies, as an extension of ongoing laboratory research in the Thoracic Oncology laboratory.
Who is eligible for this trial? (PDQ)
- Patients with radiographic evidence of, or histologically/cytologically proven, lung cancers or esophageal cancers, malignant pleural mesotheliomas, mediastinal or chest wall neoplasms, or pulmonary metastases from cancers of non-thoracic origin, are eligible for evaluation
- Patients with concomitant intracranial metastases, which are potentially treatable by surgery and/or radiation therapy, are eligible for study
- Patients must have coagulation parameters within acceptable limits by standard of practice guidelines prior to biopsy
What types of drugs or therapies are being used?
No investigational treatments will be administered to subjects enrolled on this protocol. In specific circumstances approved by the Section Chief, standard therapy may be offered to a patient who is not eligible for investigational therapy on a current Thoracic Oncology protocol, yet either presents a novel and unique clinical training opportunity, or manifests a clinical condition requiring immediate intervention to prevent compromise to his/her well-being.
What is the study outline? (PDQ)
- Participants undergo standard tests for evaluating the stage of their disease and for determining their eligibility for participation in an NCI treatment study
- Participants undergo bronchoscopy and bronchoalveolar lavage, standard tumor assessment procedures
- Participants undergo tumor biopsy
- Treatment options are discussed after the patient's cancer is staged
- Patients who are eligible for a treatment study at NCI are offered participation in the study
- Patients for whom standard surgery, radiation, or chemotherapy is more appropriate may receive treatment at NCI or with their own physician
- Patients who receive treatment at NCI return for follow-up examinations 4 weeks after discharge and then every 2-4 months depending on the nature of their cancer
What is the frequency and duration of the visits?
The patient will be evaluated according to guidelines of standard medical care and standard research laboratory procedures. The medical procedures/tests will be selected on the basis of the individual's diagnosis, prior treatment, and other supporting clinical data, and will be seen as necessary.
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.
Principal 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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