search
Back to results

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

Primary Purpose

Esophageal Cancer, Lung Cancer, Malignant Mesothelioma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
decitabine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • Center for Cancer Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 28, 2015
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00019825
Brief Title
Decitabine in Treating Patients With Unresectable Lung or Esophageal Cancer or Malignant Mesothelioma of the Pleura
Official Title
Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
decitabine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Schrump, MD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
Center for Cancer Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11265773
Citation
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.
Results Reference
background
PubMed Identifier
11216765
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. doi: 10.1016/s0003-4975(00)02421-8.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs