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

NCT01575782 | Terminated Phase 1

• 1 other identifier: CHLOROQUINE I-III
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Keywords

small cell lung cancer; stage I-III; chloroquine; Phase I

Outcome Measures

Primary Outcomes (1)

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

  3 months after inclusion

Secondary Outcomes (2)

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

  2 years after inclusion

• Overall survival

  2 years after inclusion

Study Arms (1)

Chloroquine

EXPERIMENTAL

Drug: Chloroquine

Interventions

Chloroquine DRUG

Daily intake of Chloroquine during radiotherapy

Also known as: A-CQ 100mg per tablet

Chloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \- The opposite of the above

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Philippe Lambin, MD, PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 11, 2012
• Study Start: May 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Locations

NL (1)