Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT01931787

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Comprehensive Cancer Center of Wake Forest University
Winston-Salem North Carolina, 27157, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT01931787

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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