Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies

Pleural Effusion, Malignant Clinical Trial

— PDT-lipo  

Official title:

Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies: a Clinical Phase I Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02702700
• Other study ID #: CHUV-DO-PDT-2015
• Status: Terminated
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: August 28, 2018

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study aims to explore intrapleural low-dose Visudyne®-mediated photodynamic therapy (photo-induction) as a pathway to promote the uptake of systemically administered Lipoplatin™ in pleural malignancies of patients undergoing video-assisted talcage for their malignant pleural effusions. Photo-induction is expected to overcome the chemo-resistance of pleural malignancies for cisplatin-based chemotherapeutics and thereby improve local tumor control.

Description:

The primary objective of the study is to assess the safety and tolerability of intrapleural Visudyne®-mediated photo-induction as a means to selectively increase tumor uptake of systemically administered Lipoplatin™ in patients with primary or secondary pleural malignancies.

The secondary objectives are:

Assessment of treatment efficacy as measured by dyspnea reduction, pleural effusion free survival as well as local relapse rate, progression free and median overall survival.

Analysis of the pleural intratumor penetration of Lipoplatin™ by repeated biopsies for Lipoplatin concentration measurements before and after Visudyne® treatment as well as vessel modulation related parameters (pericyte coverage, vessels morphology).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

• Stage IV breast, ovarian, gastric, colorectal, germ cell, lung, bladder, sarcoma or head and neck carcinoma requiring systemic chemotherapy OR alternatively

• Stage I/II malignant pleural mesothelioma OR alternatively

• Stage III/IV mesothelioma requiring systemic chemotherapy OR alternatively

• Stage IVa thymic malignancies AND

• Cytologically proven malignant pleural effusion requiring VATS pleurodesis

• PS 0-1

• Age 18-80

• Written informed content

• Life expectancy >3 months

• Laboratory Requirements - within 28 days prior to enrollment:

• Haematology:

• absolute granulocytes =1× 109/L

• platelets =100 × 109/L

• leukocytes =3 × 109

• Biochemistry:

• Bilirubin =3 × upper limit of normal (<5x if liver metastasis present)

• AST(SGOT) =2.5 × upper limit of normal (<5x if liver metastasis present)

• Creatinine clearance =50 mL/min according to Cockroft and Gault

• No major cardio-pulmonary co-morbidity precluding a surgical approach according to local standards

• Enrollment decision at the institutional multidisciplinary tumor board

• Patient must be willing to use effective methods of contraception. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least of 3 months after the study treatment. Male patients must agree to use a barrier method (condom) for 3 months after study treatment.

Exclusion criteria

• Grade >2 peripheral neuropathy

• Any concurrent anticancer systemic therapy within 14 days before the study intervention

• Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study e.g. Known or suspected allergy to the investigational agent or any agent given in association with this trial.

Clinically serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.

• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results

• Severe interstitial pneumonia or pulmonary fibrosis

• Chronic corticosteroid use at equivalent dose of >30mg/d methylprednisolone

• Pregnancy or breast-feeding

• Porphyria

• Severe liver insufficiency

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• Cisplatin, liposomal
Lipoplatin IV 200 mg/m2
• Verteporfin
Visudyne® IV 3 mg/m2

Device:
• Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry
Intrapleural photo-induction will be realized in the chest cavity with low-dose PDT using Visudyne® 3mg/m2 as photosensitizer, activated by 689 nm laser light with a fluence of 10J/cm2 and a fluence rate of <10mWcm2.

Locations

Country	Name	City	State
Switzerland	Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne	Vaud (VD)

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the treatment as assessed by 30-day postoperative mortality	survival status at 30 days	30 days
Primary	Tolerability of the treatment as assessed by 30-day postoperative mortality	survival status at 30 days	30 days
Primary	Feasibility	survival status at 30 days	30 days
Primary	Acute respiratory failure rate		30-day postoperative
Primary	Dyspnea according to CTCAE v4.0		30-day postoperative
Primary	Chest pain rate according to CTCAE v4.0		30-day postoperative
Primary	Dyspnea according to Medical Research Council (MRC) chronic dyspnea scale (5-point)		30-day postoperative
Secondary	Malignant effusion recurrence-free - percentage of patients without recurrent pleural effusion at 30 days		30 days after treatment
Secondary	Dyspnea reduction according to CTCAE v4.0	CTCAE v4.0	30 days after treatment
Secondary	Tumor response	Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	according to local standard
Secondary	Overall survival (OS)		every 3 months up to 3 years
Secondary	Overall response rate (ORR) based on investigator assessment according to Response	Evaluation Criteria in Solid Tumors (RECIST) version 1.1	according to local standard
Secondary	Progression-free survival (PFS)	Evaluation Criteria in Solid Tumors (RECIST) version 1.1	according to local standard
Secondary	Duration of Response (DOR)	Evaluation Criteria in Solid Tumors (RECIST) version 1.1	according to local standard