Lung Cancer Clinical Trial
Official title:
Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients
Verified date | July 2004 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Cancer Research | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Weiser TS, Guo ZS, Ohnmacht GA, Parkhurst ML, Tong-On P, Marincola FM, Fischette MR, Yu X, Chen GA, Hong JA, Stewart JH, Nguyen DM, Rosenberg SA, Schrump DS. Sequential 5-Aza-2 deoxycytidine-depsipeptide FR901228 treatment induces apoptosis preferentially in cancer cells and facilitates their recognition by cytolytic T lymphocytes specific for NY-ESO-1. J Immunother. 2001 Mar-Apr;24(2):151-61. — View Citation
Weiser TS, Ohnmacht GA, Guo ZS, Fischette MR, Chen GA, Hong JA, Nguyen DM, Schrump DS. Induction of MAGE-3 expression in lung and esophageal cancer cells. Ann Thorac Surg. 2001 Jan;71(1):295-301; discussion 301-2. — View Citation
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