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Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies (PDT-lipo)

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ClinicalTrials.gov Identifier: NCT02702700
Recruitment Status : Terminated (Drug supply issue)
First Posted : March 9, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Solange Peters, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Pleural Effusion, Malignant Drug: Cisplatin, liposomal Drug: Verteporfin Device: Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry Phase 1

Detailed 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies: a Clinical Phase I Trial
Study Start Date : January 2016
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lipoplatin/Visudyne-mediated photodynamic therapy
200 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.
Drug: Cisplatin, liposomal
Lipoplatin IV 200 mg/m2
Other Name: Lipoplatin™

Drug: Verteporfin
Visudyne® IV 3 mg/m2
Other Name: Visudyne®

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.




Primary Outcome Measures :
  1. Safety of the treatment as assessed by 30-day postoperative mortality [ Time Frame: 30 days ]
    survival status at 30 days

  2. Tolerability of the treatment as assessed by 30-day postoperative mortality [ Time Frame: 30 days ]
    survival status at 30 days

  3. Feasibility [ Time Frame: 30 days ]
    survival status at 30 days

  4. Acute respiratory failure rate [ Time Frame: 30-day postoperative ]
  5. Dyspnea according to CTCAE v4.0 [ Time Frame: 30-day postoperative ]
  6. Chest pain rate according to CTCAE v4.0 [ Time Frame: 30-day postoperative ]
  7. Dyspnea according to Medical Research Council (MRC) chronic dyspnea scale (5-point) [ Time Frame: 30-day postoperative ]

Secondary Outcome Measures :
  1. Malignant effusion recurrence-free - percentage of patients without recurrent pleural effusion at 30 days [ Time Frame: 30 days after treatment ]
  2. Dyspnea reduction according to CTCAE v4.0 [ Time Frame: 30 days after treatment ]
    CTCAE v4.0

  3. Tumor response [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  4. Overall survival (OS) [ Time Frame: every 3 months up to 3 years ]
  5. Overall response rate (ORR) based on investigator assessment according to Response [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  6. Progression-free survival (PFS) [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  7. Duration of Response (DOR) [ Time Frame: according to local standard ]
    Evaluation Criteria in Solid Tumors (RECIST) version 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702700


Locations
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Switzerland
Oncology Department, Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Vaud (VD), Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Study Director: Hans-Beat Ris, MD, Prof. CHUV

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Responsible Party: Solange Peters, Associate physician, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02702700     History of Changes
Other Study ID Numbers: CHUV-DO-PDT-2015
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Verteporfin
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents