Safety and Effectiveness of MPCD Therapy on the Treatment of Malignant Pleural Effusion

Breast Cancer Clinical Trial

Official title:

Safety and Effectiveness of Microparticles Packaging Chemotherapeutic Drugs(MPCD) Therapy on the Treatment of Malignant Pleural Effusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04131231
• Other study ID #: NCC20180327
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: October 2019
• Source: Peking Union Medical College
• Contact: Fei Ma, MD
• Phone: 8613910217780
• Email: drmafei[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label , multicenter randomized controlled trial, with 248 cases in 50 centers planned for a period of 2 years. The aim of the study is to evaluate the safety and effectiveness of microparticles packaging chemotherapeutic drugs (MPCD) therapy on the treatment of malignant pleural effusion (MPE) in patients with advanced lung cancer or breast cancer.

Description:

After obtaining informed consent, patients who meet the eligibility criteria will be randomly assigned 1:1 to treatment either with MPCD or recombinant human interleukin-2(rhIL-2) for injection. Randomization is stratified by tumor type and previous treatment. Patients in the MPCD group are first treated with microparticles packaging methotrexate (MPs-MTX) via intrapleural infusion four times on day5,6,7,8 and then undergo chemotherapy 1 cycle from day12. Patients in the control group are first treated with rhIL-2 via intrapleural infusion three times on day5,8,11 and then undergo chemotherapy 1 cycle from day12. After 4 weeks from the beginning of the treatment (day1 of treatment), the efficacy is assessed according to the WHO (1997) Response Evaluation Criteria In MPE and the evaluation methods mainly include physical examination, ultrasound and computed tomography (CT). The patients will be monitored by telephone every three months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 248
• Est. completion date: June 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed as lung cancer or breast cancer;

2. Cytologically or histologically confirmed MPE needing thoracocentesis treatment;

3. Without thoracocentesis treatment within 4 weeks;

4. ECOG PS score: 0-2 points;

5. Predicted life expectancy greater than 3 months;

6. 18 years =Age =80 years;

7. Bone marrow function: hemoglobin(HGB) =90g/L,white blood cells(WBC) =3.0×10^9/L,absolute neutrophil count(ANC) =1.5×10^9/L,platelets (PLT) =80×10^9/L,international standardized ratio (INR) <1.5;

8. Hepatic function:alanine aminotransferase(ALT) and aspartate aminotransferase(AST) =2.5×ULN,serum total bilirubin=1.5× ULN;

9. Renal function:blood urea nitrogen(BUN) and serum creatinine(Cr) =1.5×ULN, or endogenous creatinine clearance rate(Ccr) =60mL/min;

10. Without other severe cardiac disease or respiratory disease;

11. The volunteers voluntarily join the study, sign informed consent, and have good compliance and follow-up.

Exclusion Criteria:

1. Inappropriate to receive chemotherapy;

2. Women who are pregnant, preparing to be pregnant, breastfeeding;

3. Known or suspected hypersusceptibility to any agents used in the treatment protocol;

4. With severe cardiac disease, respiratory disease, liver disease, kidney disease, or diabetes;

5. With severe infection;

6. With severe encapsulated pleural effusion or intrathoracic tissue adhesion which is inappropriate to receive thoracocentesis;

7. With cognitive impairment or low compliance;

8. Participating in other clinical trials within 4 weeks;

9. Undergoing immunotherapy within 3 months;

10. Other conditions considered to be inappropriate to be enrolled by the investigator.

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• microparticles packaging methotrexate (MPs-MTX)
50ml, intrapleural infusion, day5,6,7,8
• recombinant human interleukin-2(rhIL-2)
50ml, intrapleural infusion, day5,8,11

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate(ORR)	Percentage of patients whose pleural effusion completely recover or reduce by more than 50% for more than 4 weeks	4 weeks
Secondary	Progression Free Survival (PFS)	Time from the date of first receive treatment to the date of first documented progression or date of death from any cause whichever came first	up to 20 months
Secondary	Overall Survival(OS)	Time from the date of first receive treatment to the date of death	up to 20 months
Secondary	Level of tumor markers	The change of the level of tumor markers(CEA,CA125) in blood and pleural effusion before and after treatment	up to 20 months
Secondary	Index of pleural effusion	Routine, biochemistry and cytological examination of pleural effusion	up to 20 months