Recurrent Small Cell Lung Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Given IV
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven SCLC that has relapsed or been refractory from at least one line of chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 3 * Expected survival \> 1 month * No acute toxicities from previous treatment higher than grade 1 at the start of treatment with CPI-613 * Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation * Men must practice effective contraceptive methods during the study, unless documentation of infertility exists * Platelet count \>= 100,000 cells/mm\^3 or \>= 100 bil/L * Absolute neutrophil count (ANC) \>= 1500 cells/mm\^3 or \>= 1.5 bil/L * Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 3 x upper normal limit (UNL) * Bilirubin =\< 1.5 x UNL * Serum creatinine =\< 1.5 mg/dL or 133 µmol/L * Albumin \> 2.0 g/dL or \> 20 g/L * Mentally competent, ability to understand and willingness to sign an Institutional Review Board (IRB)-approved written informed consent form * Have access via central line (e.g., portacath)-double lumen due to CPI-613 administration requirements
Exclusion criteria
* Patients receiving any other standard or investigational treatment for their cancer, or any investigational agent for any non-cancer indication within the past 2 weeks prior to initiation of CPI-613 treatment * Serious medical illness that would potentially increase patients' risk for toxicity * Any active uncontrolled bleeding or bleeding diathesis * Pregnant women, women of child-bearing potential not using reliable means of contraception, or lactating women * Men unwilling to practice contraceptive methods during the study period * Life expectancy less than 1 month * Treatment with any anti-cancer therapy within the 2 weeks prior to treatment with CPI-613 * Patients with untreated central nervous system (CNS) or epidural tumor * Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety * Unwilling or unable to follow protocol requirements * Active heart disease including myocardial infarction within previous 6 months, symptomatic coronary artery disease, arrhythmias not controlled with medication, or symptomatic congestive heart failure * Evidence of active infection or serious infection (e.g., septic shock with multi-organ dysfunction) within the past month * Patients with known human immunodeficiency virus (HIV) infection * Requirement for immediate palliative treatment of any kind including surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) | Up to 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Up to 3 years | 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. |
| Overall survival (OS) | Up to 3 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Up to 3 years | Each toxicity identified in the protocol will be examined by grade. |
Countries
United States
Outcome results
None listed