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

Recurrent Small Cell Lung Cancer Clinical Trial

Official title:

A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931787
• Other study ID #: IRB00024405
• Secondary ID: NCI-2013-01653CC
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Recurrent Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• 6,8-bis(benzylthio)octanoic acid
Given IV

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	Each toxicity identified in the protocol will be examined by grade.	Up to 3 years
Primary	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.	Up to 3 years
Secondary	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.	Up to 3 years
Secondary	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.	Up to 3 years