A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction

Nsclc Clinical Trial

Official title:

A Phase III Single Arm Trial of PTS (Para Toluenesulfonamide Injection) Via Bronchoscopy Intervention Intratumoral Injection in Patients With Central Air Way NSCLC Tumor Severe Obstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448146
• Other study ID #: PTS302
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2018
• Last updated: February 27, 2018
• Start date: August 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2018
• Source: PTS International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway obstruction and dyspnea by improving the percentage of lumen patency of patients with central air way NSCLC tumor severe obstruction.

Description:

1. Local intratumoral injection of para toluenesulfonamide (PTS) via bronchoscopy could alleviate airway obstruction for patients with central air way NSCLC tumor severe obstruction, which contributed to the shrinkage of target tumor lesions in a short period, with an objective response rate of 66% and an improvement rate of luminal tumor obstruction of 70% in the end-of-treatment period.

2. Patient's pulmonary function, atelectasis and quality of life were improved significantly after treatment, indicating that PTS treatment cuold relieve the symptoms of air way obstruction and provide clinical benefits to the patients.

3. Adverse events were mainly blood streaked sputum, injection site haemorrhage, cough, pyrexia and oropharyngeal pain, without reporting of potential risks. Common study drug related adverse events included injection site haemorrhage, cough, and blood streaked sputum and oropharyngeal pain. The multi-center clinical study conducted strictly in accordance with Standard Operation Procedures for the Use of a Standard Bronchoscope in Local Intratumoral PTS Injection showed that PTS had good safety and tolerability and that the procedural risks of intratumoral PTS injection via bronchoscopy could be controlled.

4. The advantages of PTS for treatment of airway lung cancer obstruction included significant efficacy, good safety, large applicable population; relatively simple equipment conditions and operation, thus it could be spread easily. PTS is also expected to be used in the treatment of central lung cancer with acute airway obstruction in combination with other treatments (such as stent implantation), which provides a new drug treatment to patients with airway lung cancer obstruction. PTS can complement with other treatments, which is expected to improve the treatment efficacy significantly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 83 Years

Eligibility

Inclusion Criteria:

• Male or female inpatients, aged 18 to 83 years old.

• Patients with central air way non-small cell lung cancer (NSCLC) severe obstruction; definition of severe airway obstruction: =1/2 trachea is obstructed by tumor; and/or block =2/3 of primary bronchi, right and middle bronchi. And the longest diameter of the lesion > 0.5 cm.

• Pathologically confirmed lung cancer.

• Patients with tracheal tumor lesions suitable for local intratumoral injection via fibro-bronchoscopy.

• At least one measurable lesion that could be evaluated by imaging examination (bronchoscopy, CT, MRI or X-ray etc.) according to the Response Evaluation Criteria in Solid Tumors.

• Blood platelet count = 100,000/mm3.

• Subjects who were able to understand and comply with the trial protocol and give written consent.

Exclusion Criteria:

• Brain metastases.

• History of cardiovascular diseases, including congestive heart failure > New York Heart Association (NYHA) Grade II. Patients with unstable angina pectoris (angina pectoris symptoms at rest), recent angina pectoris (occurred in the recent 3 months) or with myocardial infarction in recent 6 months must be excluded.

• Severe infections or dysbolism.

• Poor hepatic functional reserve or severe hepatocirrhosis, with abnormal blood coagulation indicators.

• Poor general conditions or cachexia.

• The target lesion had been treated with radiotherapy within 6 months.

• Pregnant or breast-feeding woman.

• Known hypersensitivity to PTS or related compounds.

• Lung cancer lesions not suitable for local treatment.

• Any other reason deemed reasonable by the investigator.

Related Conditions & MeSH terms

• Nsclc

Intervention

Drug:
• Para-Toluenesulfonamide

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
PTS International Inc.

Country where clinical trial is conducted

China, 

References & Publications (1)

Li SY, Li Q, Guan WJ, Huang J, Yang HP, Wu GM, Jin FG, Hu CP, Chen LA, Xu GL, Liu SZ, Wu CG, Han BH, Xiang Y, Zhao JP, Wang J, Zhou X, Li HP, Zhong NS. Effects of para-toluenesulfonamide intratumoral injection on non-small cell lung carcinoma with severe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The objective response rate of target lesions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.	30 days after the last treatment
Primary	Improvement rate of luminal obstructions	The improvement rate of luminal obstructions in patients with central air way NSCLC tumor severe obstruction after PTS treatment were evaluated based on measurement results of CT and bronchoscopy.	30 days after the last treatment
Secondary	Change in FVC	Changes in Forced Vital Capacity (FVC)	30 days after the last treatment
Secondary	Change in FEV1/FVC	Changes in Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC)	30 days after the last treatment
Secondary	Change in BDI score	Changes in Baseline Dyspnea Index (BDI) score. The BDI provides a multidimensional measurement of dyspnea based on 3 domains: functional impairment, magnitude of task and magnitude of effort that evoke dyspnea in activities of daily living, in symptomatic individuals. Rated in five grades from 0 to 4 for each domain. Ranging from 0 to 12. The lower the score, the worse the severity of dyspnea.	30 days after the last treatment
Secondary	Change in pleural effusion	Changes in pleural effusion	30 days after the last treatment
Secondary	Change in ECOG performance status	Changes in Eastern Cooperative Oncology Group (ECOG) performance status	30 days after the last treatment
Secondary	Change in QOL score	Changes in Quality of Life (QOL) score. Quality of life (QOL) was evaluated based on the subject's answers in Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) questionnaire, version 4. Symptoms of lung cancer were evaluated according to the completed Lung Cancer Subscale (LCS). The FACT-LCS, version 4 is a patient completed questionnaire consisting 36 items that assesses health related quality of life (HRQL) in lung cancer patients. The FACT-LCS, version 4 consists of the 27-item FACT-G assessing generic HRQL concerns and 9-item Lung Cancer Subscale assessing disease-specific issues. Instrument scoring yields a range from 0 to 144 with higher scores representing better patient status.	30 days after the last treatment
Secondary	Duration of response (DOR) of target lesion	Duration of response (DOR) of target lesion	30 days after the last treatment