This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria. SECONDARY OBJECTIVES: I. To estimate the time to progression and overall survival in this patient population. II. To examine the toxicity profile of SAHA. TERTIARY OBJECTIVES: I. To evaluate the molecular activity of SAHA by evaluating its effect on histone acetylation, upregulation of target genes, generation of reactive oxygen species, apoptosis and correlation with P53 status. II. To explore gene expression profiles that predict response to SAHA. OUTLINE: This is a multicenter study. Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 1 month and then every 3 months for 1 year or until disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Given PO
Correlative studies
St. Vincent Regional Cancer Center CCOP
Green Bay, Wisconsin, United States
Gundersen Lutheran
La Crosse, Wisconsin, United States
UW Health Oncology - 1 South Park
Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Response Per RECIST Criteria
Per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.
Time frame: Time from treatment initiation until the end of treatment. The median number of cycles was 3 (range 1-27)
Time to Progression
Time to progression per Response Evaluation Criteria In Solid Tumors and assessed by CT: Complete Response(CR), Disappearance of all target lesions; Partial Response(PR),\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response(OR) = CR + PR.
Time frame: From start of treatment to progression (average was 3.7 months)
Overall Survial
Overall survial of subjects from the start of treatment to the time of death
Time frame: From treatment start to time of death
Toxicity
Number of participants experiencing adverse events possibly related to SAHA from first dose of treatment until 30 days from the last dose of treatment.
Time frame: From first dose of treatment until 30 days from the last dose of treatment
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