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Trial record 15 of 158 for:    Chloroquine phosphate

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

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ClinicalTrials.gov Identifier: NCT01575782
Recruitment Status : Terminated (Poor accrual)
First Posted : April 11, 2012
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Maastricht Radiation Oncology

Brief 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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Chloroquine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chloroquine as an Anti-autophagic Radiosensitizing Drug in Stage I-III Small Cell Lung Cancer (SCLC) Patients: a Phase I Trial.
Actual Study Start Date : May 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Chloroquine Drug: Chloroquine
Daily intake of Chloroquine during radiotherapy
Other Name: A-CQ 100mg per tablet




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months after inclusion ]

Secondary Outcome Measures :
  1. Response of the tumour (regression, progression, stable disease) [ Time Frame: 2 years after inclusion ]
  2. Overall survival [ Time Frame: 2 years after inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575782


Locations
Netherlands
MAASTRO clinic
Maastricht, Limburg, Netherlands, 6229 ET
Sponsors and Collaborators
Maastricht Radiation Oncology
Investigators
Principal Investigator: Philippe Lambin, MD, PhD Maastro Clinic, The Netherlands

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01575782     History of Changes
Other Study ID Numbers: CHLOROQUINE I-III
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Maastricht Radiation Oncology:
small cell lung cancer
stage I-III
chloroquine
Phase I

Additional relevant MeSH terms:
Chloroquine
Chloroquine diphosphate
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics