CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Thioctic Acid

Criteria

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