Clinical trial NCT01931787: CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Official title: A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent Small Cell Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-08-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 3 years
measure: Overall survival (OS)
timeFrame: Up to 3 years
Other outcomes:
measure: Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
timeFrame: Up to 3 years
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jimmy Ruiz
role: PRINCIPAL_INVESTIGATOR
References: