Phase I study of decitabine-mediated induction of tumor antigen and tumor suppressor gene expression in lung cancer patients

Originating Group

Thoracic Oncology Section, Surgery Branch, NCI, Bethesda, MD

P.I.: Dr. David S. Schrump

Participating Groups

None

Objectives

1. Evaluation of pharmacokinetics and toxicity of continuous 72 hour intravenous infusion of decitabine in lung cancer patients.
2. Analysis of NY-ESO-1 expression in lung cancer specimens before and after decitabine treatment.
3. Analysis of serologic response to NY-ESO-1 before and after decitabine treatment.
4. Analysis of p16 tumor suppressor gene expression before and after decitabine treatment.

Eligibility

1. Histologically or sytologically-proven primary small cell or non-small cell lung cancer with no evidence of intracranial or leptomeningeal metastases.
2. No chemotherapy, biologic therapy, or radiation therapy within 30 days prior to decitabine treatment.
3. ECOG performance status 0-2.
4. FEV 1.0 and DLCO greater than 40% predicted; pCO2 greater than 45mmHg, and pO2 greater than 60mmHg on room air
5. Platelet count greater than 100,000, Hgb greater than 10gm/dl, WBC greater than 3,500/ul, normal PT/PTT and adequate hepatic function as evidence by a total bilirubin of less than 1.5x the upper limit of normal. Serum creatinine less than or equal to 1.6mg/ml or the creatinine clearance must be greater than 60ml/min.
6. The patient must be winning to sign an informed consent, and undergo tumor biopsies to evaluate NY-ESO-1 and p16 expression prior to, and after decitabine treatment.

Schema

Not Available

Comments

Activated 10/1999

Target Accrual 20 patients

Accrual 1/20 as of 12/1999