OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.

NCT06421610 | Recruiting Phase 1 DMC

• 1 other identifier: PITAC-OPC5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).

Conditions

Malignant Pleural Effusion; Pleural Neoplasms; Quality of Life; Chemotherapy Effect; Chemotherapeutic Toxicity; Pleural Carcinomatosis; Pleural Cavity Effusion

Outcome Measures

Primary Outcomes (2)

• Medical adverse events

  Number of patients with medical adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 defined as CTCAE ≥ 4 within 30 days after the procedure.

  30 days from PITAC directed treatment

• Surgical complications

  Number of patients with surgical complications according to the Clavien-Dindo classification defined as Clavien-Dindo ≥ 3b within 30 days after the procedure.

  30 days from PITAC directed treatment

Secondary Outcomes (16)

• Number of patients completing three PITAC treatments

  12 months

• Extent of visible pleural metastasis

  12 months

• Pathology on pleural metastasis biopsies

  12 months

• Cytology on malignant pleural effusion fluid

  12 months

• LENT score

  12 months

Study Arms (1)

PITAC

EXPERIMENTAL

Malignant Pleural Effusion (MPE) from colorectal or appendix cancer will be treated with Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. MPE from non-colorectal or -appendix cancer will be treated with PITAC using cisplatin 10.5 mg/m2 in 150 ml saline and 2.1 mg/m2 in 50 ml saline. PITAC is performed with a intrapleural pressure of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 300 PSI and a flow-rate of 0.5-1.8 ml/min. The PITAC directed treatment will be planned with 4 week intervals and patients may receive bi-directional systemic chemotherapy simultaneously.

Drug: PITAC

Interventions

PITAC DRUG

Cisplatin, oxaliplatin and doxorubicin are standard, commercially available intravenous cytostatic drugs in oncologic treatment with alkylating and topoisomerase inhibitor effect, respectively. Based on the available data and experience from 11 PITAC procedures at OPC, PITAC with cisplatin, oxaliplatin and doxorubicin for intrapleural administration is expected to be well tolerated with a minimal of nausea, subcutaneous emphysema and transient chest pains.

PITAC

Eligibility Criteria

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

You may qualify if:

• Symptomatic MPE visible with bedside ultrasound
• Histologically or cytologically verified malignancy
• Status CT-scan not older than four weeks
• MPE requiring at least one drainage procedure
• Drained ≥ 14 days before the first PITAC directed treatment
• Bidirectional systemic chemotherapy or immunotherapy ≥ 14 days before the first PITAC directed treatment or no simultaneous systemic chemotherapy or immunotherapy
• ECOG Performance status 0-2
• Life expectancy ≥ 3 months
• Age ≥ 18 years
• Danish-speaking and reading patients
• Written informed consent according to the local Ethics Committee requirements

You may not qualify if:

• A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin
• Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation)
• Myocardial insufficiency, defined as NYHA class \> 2
• Impaired liver function defined as bilirubin ≥1.5
• Fertility, pregnancy and lactation: Female subjects will be considered of non-reproductive potential if they are either a, b or c:
• postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women \< 45 years of age a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to screening.
• have a congenital or acquired condition that prevents childbearing. Previous intrathoracic chemotherapy, intrathoracic antibody treatment or chemical pleurodesis
• Any other condition or therapy, which in the investigator´s opinion may pose a risk to the patient or interfere with the study objects

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense PIPAC Center, Department of Surgery, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Pleural Effusion, Malignant; Pleural Neoplasms; Pleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Diseases; Respiratory Tract Diseases

Central Study Contacts

Pernille Schjødt Hansen, Student

CONTACT

+45 65411857; pernille.schjodt.hansen@rsyd.dk

Study Design

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

Model Details: Cohort study

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 20, 2024
• Study Start: September 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)