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

Information source: Maastricht Radiation Oncology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Cancer

Intervention: Chloroquine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Maastricht Radiation Oncology

Official(s) and/or principal investigator(s):
Philippe Lambin, MD, PhD, Principal Investigator, Affiliation: Maastro Clinic, The Netherlands

Overall contact:
Chantal Overhof-Wedick, Phone: +31 88 44 55 686, Email: chantal.overhof@maastro.nl

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.

Clinical Details

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

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

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

Secondary outcome:

Response of the tumour (regression, progression, stable disease)

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Chantal Overhof-Wedick, Phone: +31 88 44 55 686, Email: chantal.overhof@maastro.nl

MAASTRO clinic, Maastricht, Limburg 6229 ET, Netherlands; Recruiting
Chantal Overhof-Wedick, Phone: +31 88 44 55 686, Email: chantal.overhof@maastro.nl
Additional Information

Starting date: May 2014
Last updated: October 23, 2014

Page last updated: August 20, 2015

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