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Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.

Phase 1
18 Years
Not Enrolling
Small Cell Lung Cancer

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Trial Information

Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.

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

- 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

- No cardiac conduction disturbances or medication potentially causing them:

- QTc interval prolongation with other medications that required discontinuation of the

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Time Frame:

3 months after inclusion

Safety Issue:


Principal Investigator

Philippe Lambin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • Small Cell Lung Cancer
  • small cell lung cancer
  • stage I-III
  • chloroquine
  • Phase I
  • Lung Neoplasms
  • Small Cell Lung Carcinoma