This pilot clinical trial studies CPI-613 (6,8-bis\[benzylthio\]octanoic acid) in treating patients with relapsed or refractory small cell lung cancer. CPI-613 may interfere with the growth of tumor cells and may be an effective treatment for small cell lung cancer.
PRIMARY OBJECTIVES: I. To evaluate the safety and anti-cancer activities in patients with relapsed or refractory small cell lung cancer (SCLC) who have failed 1 or 2 lines of chemotherapy. OUTLINE: Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 4 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Given IV
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
The proportion of responders as the percent of patients who are SD, PR and CR will be estimated, as well as RR (sum of PR + CR) and disease control rate (DCR, which is the sum of SD, PR and CR). 95% confidence intervals will be included.
Time frame: Up to 3 years
Progression-free survival (PFS)
Survival curves for PFS will be estimated using Kaplan-Meier techniques. In addition, the 6 month and 1-year PFS rates will be estimated. Median PFS will be estimated as well.
Time frame: Up to 3 years
Overall survival (OS)
Survival curves for OS will be estimated using Kaplan-Meier techniques. In addition, the 6 month and 1-year OS rates will be estimated. Median OS will be estimated as well.
Time frame: Up to 3 years
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