Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura

NCT00019825 | Completed Phase 1

• 3 other identifiers: CDR0000067228NCI-99-C-0129NCI-T99-0012
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Esophageal Cancer; Lung Cancer; Malignant Mesothelioma; Metastatic Cancer

Keywords

recurrent non-small cell lung cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; recurrent esophageal cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; advanced malignant mesothelioma; recurrent malignant mesothelioma; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; malignant pleural effusion

Interventions

decitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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. doi: 10.1097/00002371-200103000-00010.

  PMID: 11265773 BACKGROUND

• 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. doi: 10.1016/s0003-4975(00)02421-8.

  PMID: 11216765 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms; Mesothelioma, Malignant; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Pleural Effusion, Malignant

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Effusion; Pleural Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• David S. Schrump, MD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 1999
• Last Updated: April 29, 2015

Record last verified: 2004-07

Locations

US (2)