Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have unresectable lung or esophageal cancer or malignant mesothelioma of the pleura.
Checked against the public recordLast updated Apr 29, 2015 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- National Cancer Institute (NCI)
- Interventions being studied
- Drug: decitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed unresectable primary small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC), unresectable esophageal cancer, malignant pleural mesothelioma, or pleural effusions secondary to extrathoracic malignancies * Disease must be readily accessible to biopsy by endoscopy or percutaneous fine-needle aspiration * Extrathoracic metastatic disease allowed if no evidence of active intracranial or leptomeningeal metastases * Patients treated with prior resection or radiotherapy for intracranial metastatic disease may be eligible provided there is no evidence of active disease on two MRIs (taken one month apart) and patients require no anticonvulsant medications or steroids to control residual symptoms * No limited stage SCLC or operable NSCLC PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 6 months Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL * WBC greater than 3,500/mm\^3 Hepatic: * PT normal * Bilirubin less than 1.5 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * Any of the following conditions require clearance by a cardiologist: * Prior coronary artery disease * Prior transmural myocardial infarction * Congestive heart failure * Fixed defects on thallium scan with ejection fraction greater than 40% * No unstable angina * No recent deep venous thrombosis requiring anticoagulation Pulmonary: * FEV1 and DLCO greater than 30% of predicted * pCO\_2 less than 50 mm Hg * pO\_2 greater than 60 mm Hg on room air * No recent pulmonary embolism requiring anticoagulation Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 30 days since prior biologic therapy for the malignant tumor Chemotherapy: * No prior decitabine * At least 30 days since other prior chemotherapy for the malignant tumor Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 30 days since prior radiotherapy for the malignant tumor (14 days for localized radiotherapy to nontarget lesions) and recovered Surgery: * See Disease Characteristics
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland
- Center for Cancer ResearchBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 29, 2015. Always confirm current availability with the study team.