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

NCT ID: NCT01931787

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Recurrent Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (CPI-613)

Patients receive CPI-613 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.

Group Type: EXPERIMENTAL

6,8-bis(benzylthio)octanoic acid

Intervention Type: DRUG

Given IV

Interventions

6,8-bis(benzylthio)octanoic acid

Given IV

Intervention Type: DRUG

Other Intervention Names

alpha-lipoic acid analogue CPI-613; CPI-613

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jimmy Ruiz

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2013-01653

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 62113

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00024405

Identifier Type: -

Identifier Source: org_study_id