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Clinical Trials/NL-OMON37990
NL-OMON37990CompletedNot Applicable

Chloroquine as an anti-autophagic chemosensitizing drug in stage IV small cell lung cancer (SCLC) patients: A phase I trial. - Chloroquine in small cell lung cancer

MAASTRO clinic0 sites24 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •. Histologically or cytologically confirmed stage IV disease (stage T)-4, N0-3, M1) small cell lung cancer
  • •. At least one measurable disease site, defined as lesion of * 1 cm undimensionally 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 6.2mmol/l
  • •. 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
  • •. 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 4.0), or asypmtomatic 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 lung QT-syndrome or unexplained sudden death of first degree relative under 40 years of age
  • •. QTc 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).
  • •. 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 oposite of the above

Investigators

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