- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575782
Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (Chloroquine)
July 13, 2017 updated by: Maastricht Radiation Oncology
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Limburg
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Maastricht, Limburg, Netherlands, 6229 ET
- Maastro Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Chloroquine
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Daily intake of Chloroquine during radiotherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 3 months after inclusion
|
3 months after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response of the tumour (regression, progression, stable disease)
Time Frame: 2 years after inclusion
|
2 years after inclusion
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Overall survival
Time Frame: 2 years after inclusion
|
2 years after inclusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
April 3, 2012
First Submitted That Met QC Criteria
April 10, 2012
First Posted (Estimate)
April 11, 2012
Study Record Updates
Last Update Posted (Actual)
July 18, 2017
Last Update Submitted That Met QC Criteria
July 13, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Anti-Infective Agents
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Chloroquine
Other Study ID Numbers
- CHLOROQUINE I-III
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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