Know Cancer

forgot password

Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients

Phase 1
18 Years
Not Enrolling
Esophageal Cancer, Lung Cancer, Malignant Mesothelioma, Metastatic Cancer

Thank you

Trial Information

Phase I Study of Decitabine Mediated Induction of Tumor Antigen and Tumor Suppressor Gene Expression in Lung Cancer Patients


- 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

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.

Inclusion Criteria


- 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

- Disease must be readily accessible to biopsy by endoscopy or percutaneous fine-needle

- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 6 months


- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10 g/dL

- WBC greater than 3,500/mm^3


- PT normal

- Bilirubin less than 1.5 times upper limit of normal


- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- 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


- 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


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No active infection

- HIV negative


Biologic therapy:

- At least 30 days since prior biologic therapy for the malignant tumor


- No prior decitabine

- At least 30 days since other prior chemotherapy for the malignant tumor

Endocrine therapy:

- See Disease Characteristics


- See Disease Characteristics

- At least 30 days since prior radiotherapy for the malignant tumor (14 days for
localized radiotherapy to nontarget lesions) and recovered


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Schrump, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Metastatic Cancer
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Mesothelioma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182
Center for Cancer Research Bethesda, Maryland  20892