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Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (Chloroquine)

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ClinicalTrials.gov Identifier: NCT01575782
Recruitment Status : Terminated (Poor accrual)
First Posted : April 11, 2012
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Tracking Information
First Submitted Date  ICMJE April 3, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date July 18, 2017
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months after inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2012)
  • Response of the tumour (regression, progression, stable disease) [ Time Frame: 2 years after inclusion ]
  • Overall survival [ Time Frame: 2 years after inclusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer
Official Title  ICMJE Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.
Brief Summary Chloroquine can make tumor cells less resistant to chemo/radiotherapy. In this trial chloroquine is given during radiotherapy. The dose is increased in cohorts of at least 3 patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE Drug: Chloroquine
Daily intake of Chloroquine during radiotherapy
Other Name: A-CQ 100mg per tablet
Study Arms  ICMJE Experimental: Chloroquine
Intervention: Drug: Chloroquine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 13, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2012)
24
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed stage I-III small cell lung cancer, excluding malignant pleural/pericardial effusion.
  • At least one measurable disease site, defined as lesion of ≥ 1 cm unidimensionally on CT-scan
  • WHO performance status 0-2
  • Absolute neutrophil count at least 1800/µl and platelets at least 100000/µl and hemoglobin at least 6.2 mmol/l.
  • Adequate renal function: calculated creatinine clearance at least 60 ml/min
  • Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution (in case of liver metastases ≤ 5 x ULN for the institution)
  • No previous platinum chemotherapy or topo-isomerase-inhibitors for SCLC.
  • Lung function: FEV1 at least 30 % and DLCO at least 30 % of the age predicted value
  • No history of prior chest radiotherapy
  • Life expectancy more than 6 months
  • Willing and able to comply with the study prescriptions
  • 18 years or older
  • Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study
  • Ability to give and having given written informed consent before patient registration
  • No mixed pathology, e.g. non-small cell plus small cell cancer
  • No recent (< 3 months) severe cardiac disease (NYHA class >1) (congestive heart failure, infarction)
  • No history of cardiac arrythmia (multifocal premature ventricular contractions, uncontrolled atrial fibrillation, bigeminy, trigeminy, ventricular tachycardia) which is symptomatic and requiring treatment (CTC AE 3.0), or asymptomatic sustained ventricular tachycardia. Asymptomatic atrial fibrillation controlled on medication is allowed.
  • No cardiac conduction disturbances or medication potentially causing them:
  • QTc interval prolongation with other medications that required discontinuation of the treatment
  • Congenital long QT-syndrome or unexplained sudden death of first degree relative under 40 years of age
  • QT interval > 480 msec (note: when this is the case on screening ECG, the ECG may be repeated twice. If the average QT-interval of these 3 measurements remains below 480 msec, patient is eligible)
  • Patients on medication potentially prolongating the QT-interval are excluded if the QT-interval is > 460 msec (Appendix, table 2).
  • Medication that might cause QT-prolongation or Torsades de pointes tachycardia is not allowed (Appendix, Table 1). Drugs with a risk of prolongating the QT-interval that cannot be discontinued are allowed, however, under close monitoring by the treating physician (Appendix, table 2).
  • Complete left bundle branch block
  • No uncontrolled infectious disease
  • No other active malignancy
  • No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy) in previous 4 weeks
  • No treatment with investigational drugs in 4 weeks prior to or during this study
  • No chronic systemic immune therapy
  • No known G6PD deficiency
  • Patients must not have psoriasis or porphyria.
  • No known hypersensitivity to 4-aminoquinoline compound.
  • Patients must not have retinal or visual field changes from prior 4-aminoquinoline compound use.
  • No known prior hypersensitivity to cisplatin, etoposide or chloroquine or any of their components.

Exclusion Criteria:

- The opposite of the above

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575782
Other Study ID Numbers  ICMJE CHLOROQUINE I-III
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht Radiation Oncology
Study Sponsor  ICMJE Maastricht Radiation Oncology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe Lambin, MD, PhD Maastro Clinic, The Netherlands
PRS Account Maastricht Radiation Oncology
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP