Trial record 7 of 73 for:    small cell lung ca | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01931787
First received: August 27, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Recurrent Small Cell Lung Cancer
Drug: 6,8-bis(benzylthio)octanoic acid

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Clinical Trial of CPI-613 in Patients With Relapsed or Refractory Small Cell Lung Carcinoma (SCLC)

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Tumor response rates, defined as the proportion of patients who achieve complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.

  • Overall survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Incidence of toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    Each toxicity identified in the protocol will be examined by grade.


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 6,8-bis(benzylthio)octanoic acid
Given IV
Other Names:
  • alpha-lipoic acid analogue CPI-613
  • CPI-613

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01931787

Locations
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Thomas Freeman, PA-C    336-713-6914    thfreema@wakehealth.edu   
Principal Investigator: Jimmy Ruiz         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Jimmy Ruiz Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01931787     History of Changes
Other Study ID Numbers: CCCWFU 62113, NCI-2013-01653, CCCWFU 62113, P30CA012197
Study First Received: August 27, 2013
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014