CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
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.
Checked against the public recordLast updated Jul 3, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Drug: 6,8-bis(benzylthio)octanoic acid
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Comprehensive Cancer Center of Wake Forest UniversityWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 3, 2018. Always confirm current availability with the study team.