- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00019825
Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the pharmacokinetics, toxicity, and maximum tolerated dose of decitabine in patients with unresectable primary small cell or non-small cell lung cancer, unresectable esophageal cancer, or malignant pleural mesothelioma.
- Measure the expression of NY-ESO-1 in tissue samples of these patients before and after receiving this drug.
- Assess the serologic response to NY-ESO-1 in these patients before and after receiving this drug.
- Measure the expression of p16 tumor suppressor gene in these patients before and after receiving this drug.
OUTLINE: This is a dose-escalation study for each stratification group. Patients are stratified according to number of prior therapies (2 or fewer vs 3 or more).
Patients receive decitabine IV continuously on days 1-3. Treatment repeats every 5 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of the second course receive 2 additional courses.
Cohorts of 3-6 patients receive escalating doses of decitabine 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 for a particular stratum, additional patients from that stratum are treated at the MTD.
Patients are followed for 1 month.
PROJECTED ACCRUAL: A maximum of 72 patients (36 per stratum) will be accrued for this study.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Bethesda, Maryland, Forenede Stater, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
-
Bethesda, Maryland, Forenede Stater, 20892
- Center for Cancer Research
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- tilbagevendende ikke-småcellet lungekræft
- småcellet lungekræft i omfattende stadie
- tilbagevendende småcellet lungekræft
- stadium IIIB ikke-småcellet lungekræft
- fase IV ikke-småcellet lungekræft
- avanceret malignt mesotheliom
- tilbagevendende malignt mesotheliom
- stadium II kræft i spiserøret
- stadium III kræft i spiserøret
- tilbagevendende kræft i spiserøret
- stadium IV kræft i spiserøret
- ondartet pleural effusion
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Luftvejssygdomme
- Neoplasmer efter histologisk type
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Adenom
- Neoplasmer, mesotheliale
- Pleurale neoplasmer
- Lungeneoplasmer
- Esophageale neoplasmer
- Mesotheliom
- Mesotheliom, ondartet
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Decitabin
Andre undersøgelses-id-numre
- CDR0000067228
- NCI-99-C-0129
- NCI-T99-0012
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