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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041158 |
RATIONALE: Drugs used in chemotherapy, such as decitabine and FR901228, use different ways to stop tumor cells from dividing so they stop growing or die.
Using more than one drug may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of decitabine and FR901228 in treating patients with unresectable advanced lung cancer, esophageal cancer, pleural mesothelioma, or lung metastases.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer Lung Cancer Malignant Mesothelioma Metastatic Cancer |
Drug: celecoxib Drug: decitabine Drug: romidepsin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Subjects With Pulmonary and Pleural Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | May 2002 |
Estimated Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive decitabine IV continuously on days 1-3 and FR901228 (depsipeptide) IV over 4 hours on days 4 and 10. Courses repeat every 33-36 days in the absence of disease progression or unacceptable toxicity.
Sequential dose escalation of decitabine is followed by sequential dose escalation of FR901228. Cohorts of 3-6 patients receive escalating doses of decitabine and then FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Once the MTD is determined, two additional cohorts (6 lung cancer and 6 mesothelioma patients) receive decitabine and FR901228 as above at the MTD. These patients also receive oral celecoxib twice daily on days 4-34 of each course.
PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 10.8-13.5 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed primary small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), advanced esophageal cancer, or pleural mesothelioma
No active intracranial or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
NCI - Center for Cancer Research | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: Tricia Kunst, RN 301-451-1233 tricia_kunst@nih.gov | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | David S. Schrump, MD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000069448, NCI-02-C-0205, NCI-5270 |
Study First Received: | July 8, 2002 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00041158 History of Changes |
Health Authority: | Unspecified |
recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer advanced malignant mesothelioma recurrent malignant mesothelioma stage IIIA non-small cell lung cancer |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer lung metastases malignant pleural effusion stage IV esophageal cancer recurrent esophageal cancer |
Antimetabolites Thoracic Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Pleural Effusion, Malignant Anti-Bacterial Agents Respiratory Tract Diseases Lung Neoplasms Neoplasm Metastasis Digestive System Neoplasms Celecoxib Romidepsin Esophageal Cancer Decitabine |
Recurrence Carcinoma, Small Cell Pleural Effusion Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms Mesothelioma Non-small Cell Lung Cancer Esophageal Diseases Carcinoma, Non-Small-Cell Lung Adenoma Neoplasms, Glandular and Epithelial |
Antimetabolites Thoracic Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Neoplasms, Mesothelial Esophageal Neoplasms Antibiotics, Antineoplastic Neoplastic Processes Neoplasms by Site Pathologic Processes Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Neoplasm Metastasis Respiratory Tract Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Romidepsin Enzyme Inhibitors Decitabine Pharmacologic Actions Neoplasms Digestive System Diseases Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms Mesothelioma Esophageal Diseases |