Treatment Pleural Carcinosis of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin Administration

NCT06281860 | Recruiting Phase 1 DMC

• 2 other identifiers: PITHAC2023-00099
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Within the context of pleural carcinosis, the present study is a dose escalation with determination of the maximum tolerated doses (MTD) of pressurized cisplatin administration associated to moderate hyperthermia in the pleura. This will be followed by an expansion phase at the recommended dose (RD).

Conditions

Mesothelioma, Malignant; Carcinoma, Non-Small-Cell Lung; Carcinoma Breast Stage IV; Ovarian Cancer; Esophageal Cancer; Gastric Cancer

Keywords

Pressurized intrathoracic hyperthermic aerosol chemotherapy

Outcome Measures

Primary Outcomes (2)

• Dose Escalation and Maximum Tolerated Dose determination (Part A):

  In order to determine the maximum tolerated dose (MTD) of cisplatin administered by PITHAC, the primary study outcome will be the occurrence of Dose Limiting Toxicities (DLT).

  18 months approximately

• Expansion phase (Part B):

  Safety profile of cisplatin administered by PITHAC will be assessed by the incidence of Adverse Events and Serious Adverse Events according to NCI-CTCAE criteria (v5). Incidence and severity of intraoperative and post-operative complications will be measured using the Clavien-Dindo classification up to 30 days after the intervention. Safety profile of cisplatin administered by PITHAC will be assessed by the incidence of Adverse Events and Serious Adverse Events according to NCI-CTCAE criteria (v5). Incidence and severity of intraoperative and post-operative complications will be measured using the Clavien-Dindo classification up to 30 days after the intervention.

  between 10 and 12 months

Secondary Outcomes (2)

• Dose Escalation and MTD determination (Part A):

  18 months

• Expansion phase (Part B):

  10 /12 months

Other Outcomes (2)

• Dose Escalation and MTD determination (Part A):Exploratory outcomes

  18 months approximately

• Expansion phase (Part B):Exploratory outcomes

  between 10 and 12 months

Study Arms (4)

Cohorte 1 _ 7.5 mg/m2

EXPERIMENTAL

cohorte 1: 7.5 mg/m2 of cisplatin (once)

Drug: Cisplatine Teva®

Cohorte 2 _ 12.5 mg/m2

EXPERIMENTAL

cohorte 2: 12.5 mg/m2 of cisplatin (once)

Drug: Cisplatine Teva®

cohorte 3: 35 mg/m2 of cisplatin

EXPERIMENTAL

cohorte 3: 35 mg/m2 of cisplatin (once)

Drug: Cisplatine Teva®

cohorte 4: 70 mg/m2 of cisplatin

EXPERIMENTAL

cohorte 4: 70 mg/m2 of cisplatin (once)

Drug: Cisplatine Teva®

Interventions

Cisplatine Teva® DRUG

PITHAC: Cisplatin (Cisplatine Teva®) at a dose between 7.5 and 70 mg/m2 of body surface at a temperature of 39±1°C

Also known as: Procedure/Surgery

Cohorte 1 _ 7.5 mg/m2; Cohorte 2 _ 12.5 mg/m2; cohorte 3: 35 mg/m2 of cisplatin; cohorte 4: 70 mg/m2 of cisplatin

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Body weight at least 30 kg
• Eastern cooperative oncology group performance status score of 0-2 at enrolment
• Patient with pleural carcinosis that qualify for a surgical intervention for pleurodesis or placement of an indwelling permanent catheter.
• Life expectancy of at least 3 months
• Pathology-confirmed pleural carcinosis with malignant pleural effusion (either histological confirmation is already available based on a previous tru-cut pleural biopsy or previous pleural fluid cytology is positive for malignant cells or high suspicion of pleural carcinosis based on computed tomography imaging which must be confirmed by fresh frozen section analyses of tissue harvested during pithac operative procedure)
• Non-small cell lung cancer, breast cancer, lymphoma, ovarian cancer, oesophageal cancer, gastric cancer, and malignant tumour of the serous membranes (mesothelioma) confirmed by pathology either as part of a diagnostic workup of suspected pleural carcinosis OR available from other previous examinations patients undergoing a planned videothoracoscopy to perform pleurodesis or a placement of a tunnelled catheter
• Adequate liver, kidney, and bone marrow functions as assessed by laboratory tests (serum total bilirubin \<1.5 mg/dl, aspartate transaminase and alanine transaminase less than 2.5 times the upper limit of the normal range, creatinine clearance ≥60 ml/min, absolute neutrophil count ≥1,500/μl, haemoglobin ≥90 g/L, platelets ≥100,000/μl)
• I) Patients with past/resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \[anti-HBc\] antibody test) are eligible, if HBV DNA test is negative. Ii) HBV DNA must be obtained in patients with positive hepatitis B core antibody prior start of study treatment.
• Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA
• Adequate cardiac functions as assessed by echocardiography
• Adequate birth control measures
• Signed informed consent

You may not qualify if:

• Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test at pre-screening)
• Patients with active hepatitis C
• Any known formal contra-indication for video-assisted thoracoscopy (VATS) according to pulmonary and cardiac preliminary investigations.
• Systemic cytotoxic anticancer treatment within 10 days before and after enrolment except for inhibitors of vascular endothelial growth factor for which this period should be decided according to the used drug (for bevacizumab the period involves 4 weeks before and after enrolment, for lenvatinib 1 week before and 2 weeks after, and for sorafenib 1 week before and after), no limitations applied for immune checkpoint inhibitors
• Major surgery within 28 days prior to enrolment
• Long lasting exposure to corticosteroids
• Known allergy to platinum compounds
• Non-small cell lung cancer with egfr or alk mutations unless refractory to tyrosine kinase inhibitor (thus off treatment)
• Uncontrolled intercurrent illness
• Clinically relevant hearing loss or tinnitus
• Clinically relevant neuropathy
• Life-threatening conditions (uncontrolled systemic infection etc.)
• Previous administration (by any route) of a total cumulative dose of more than 500 mg/m2 of cisplatin
• Secondary resistance to platinum compounds defined as tumour progression during platinum treatment or within 6 months after its cessation
• pregnancy

Sponsors & Collaborators

• Dr Jean Yannis PERENTES: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Switzerland

RECRUITING

Related Publications (1)

• Chriqui LE, Abdelnour-Berchtold E, Zanfrini E, Devesa-Perez S, Gonzalez M, Krueger T, Ellefsen K, Destaillats A, Bonnet D, Hubner M, Bouchaab H, Bassani-Sternberg M, Peters S, Cavin S, Perentes JY. Phase I clinical trial testing the dose escalation and expansion of Pressurized IntraThoracic Hyperthermic Aerosol Cisplatin administration (PITHAC) for the management of pleural carcinosis. Cancer Treat Res Commun. 2024;42:100858. doi: 10.1016/j.ctarc.2024.100858. Epub 2024 Dec 17.

  PMID: 39708537 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant; Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Ovarian Neoplasms; Esophageal Neoplasms; Stomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jean-Yannis Perentes

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Yannis H Perentes

CONTACT

0795560876; jean.perentes@chuv.ch

Séverine Devesa-Perez

CONTACT

795567289; Severine.Devesa-Perez@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Open-label, non-randomised monocentric Phase I clinical trial study with cisplatin dose escalation administered by PITHAC.

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: February 28, 2024
• Study Start: November 24, 2023
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CH (1)