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Small Cell Lung CancerPhase 1ChloroquineNCT01575782

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

A Phase 1 study testing Chloroquine in people with Small Cell Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Chloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteNetherlands
Study dates
May 2014to Jul 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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.

Who cannot join

  • The opposite of the above

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • MAASTRO clinic

    Maastricht, Limburg, 6229 ET

Other trials in Netherlands

About this study

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

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.

Being tested
Chloroquine
Keywords
small cell lung cancer, stage I-III, chloroquine, Phase I
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChloroquineDrug

    Also called A-CQ 100mg per tablet

    Daily intake of Chloroquine during radiotherapy

Study groups in NCT01575782
Study groupRoleWhat they receive
ChloroquineExperimentalNot described
Receives: Drug: Chloroquine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months after inclusion

Secondary outcomes (2)

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

    Measured: 2 years after inclusion

  2. Overall survival

    Measured: 2 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2012 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2017
  4. Study completionJul 2017

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01575782
Sponsor's protocol ID
CHLOROQUINE I-III
Acronym
Chloroquine
Status last verified
Jul 2017
First submitted
3 Apr 2012
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Chloroquine in people with Small Cell Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Poor accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01575782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.

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