Study Stopped
Drug supply issue
Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies
PDT-lipo
1 other identifier
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
March 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2018
CompletedMarch 20, 2019
March 1, 2019
2.7 years
January 25, 2016
March 18, 2019
Conditions
Outcome Measures
Primary Outcomes (7)
Safety of the treatment as assessed by 30-day postoperative mortality
survival status at 30 days
30 days
Tolerability of the treatment as assessed by 30-day postoperative mortality
survival status at 30 days
30 days
Feasibility
survival status at 30 days
30 days
Acute respiratory failure rate
30-day postoperative
Dyspnea according to CTCAE v4.0
30-day postoperative
Chest pain rate according to CTCAE v4.0
30-day postoperative
Dyspnea according to Medical Research Council (MRC) chronic dyspnea scale (5-point)
30-day postoperative
Secondary Outcomes (7)
Malignant effusion recurrence-free - percentage of patients without recurrent pleural effusion at 30 days
30 days after treatment
Dyspnea reduction according to CTCAE v4.0
30 days after treatment
Tumor response
according to local standard
Overall survival (OS)
every 3 months up to 3 years
Overall response rate (ORR) based on investigator assessment according to Response
according to local standard
- +2 more secondary outcomes
Study Arms (1)
Lipoplatin/Visudyne-mediated photodynamic therapy
EXPERIMENTAL200 mg/m2 Lipoplatin™ will be delivered as iv perfusion. Then, intrapleural photo-induction will be realized through a classical video-assisted thoracoscopic (VATS) approach using 3 mg/m2 Visudyne® activated at 689 nm. At the end of the procedure, the patients will receive chemical pleurodesis by VATS as per standard-of-care treatment for malignant pleural effusion.
Interventions
Lipoplatin IV 200 mg/m2
Visudyne® IV 3 mg/m2
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.
Eligibility Criteria
You may qualify if:
- 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:
- +6 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Vaud (VD), 1011, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hans-Beat Ris, MD, Prof.
CHUV
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate physician
Study Record Dates
First Submitted
January 25, 2016
First Posted
March 9, 2016
Study Start
January 1, 2016
Primary Completion
August 28, 2018
Study Completion
August 28, 2018
Last Updated
March 20, 2019
Record last verified: 2019-03