AzTrials
AzTrials

Malignant Pleural MesotheliomaPhase 1/2NCT01644994

Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma

A Phase 1/2 study testing intracavitary cisplatin-fibrin in people with Malignant Pleural Mesothelioma, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Pleural Mesothelioma
What is being tested?
intracavitary cisplatin-fibrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteSwitzerland
Study dates
Nov 2012to Aug 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is able to understand and willing to sign a written informed consent document.
  • Male or female, age >=18 years
  • ECOG performance status =<2 (ECOG = Eastern Cooperative Oncology Group)
  • Resectable MPM (Malignant Pleural Mesothelioma) histologically confirmed (phase I: stage cT1-cT4 cN0-cN3 cM0-cM1 / phase II: stage cT1-cT3 cN0-cN1 cM0) (TNM Tumor staging abbreviations: c = clinical; T = Tumor, N = lymph Nodes, M = Metastases; numbers = quantity)
  • Only Phase II: Mediastinal staging (cytological or histological)
  • Only Phase II: Induction chemotherapy (3 or more cycles cisplatin or carboplatin (also in combination with other therapeutic agents)
Show all 11Show fewer
  • Patient qualifying for (extended) pleurectomy/decortication ((e)P/D) or extrapleural pneumonectomy (EPP) for resection of MPM, which has to be assessed during a multidisciplinary tumor board including a thoracic surgeon
  • Patient must have appropriate organ and bone marrow function as defined: hematologic function: hemoglobin ≥100 g/L, WBC (white blood cell count) ≥3.5 G/L, neutrophils ≥1.5 G/L, thrombocytes ≥100 G/L; liver function: total bilirubin and LDH (lactate dehydrogenase) ≤1.5 x ULN (upper limit of normal); AST (aspartate aminotransferase), ALT (alanine aminotransferase), GGT (gamma glutamyltransferase), and AP (alkaline phosphatase) ≤2.5 x ULN; renal function: creatinine ≤130 μmol/L or, if greater, creatinine clearance ≥60 ml/min/1.73m2.
  • Patient must have an appropriate blood coagulation for P/D or EPP (Quick-test > 50%, INR (international normalized ratio) <=1.2)
  • The patient agrees to use an efficient contraceptive treatment up to 3 months after cisplatin application if required (pre-menopausal women and men in a sexually mature age).
  • Heart and lung function allowing P/D under general anesthesia

Who cannot join

  • Known or suspected unwillingness of the patient to follow the rules of the protocol
  • Patient who has not recovered from side effects from prior chemotherapy or radiotherapy.
  • Any known hypersensitivity against cisplatin or other platinum containing substances or any other components used for the preparation of the drugs.
  • Patient must not receive any other investigational agents 4 weeks before treatment and until the end of the observation period (2 months after treatment).
  • Patient with prior ipsilateral pleurectomy
  • Only Phase II: Multimodality Prognostic Score (MMPS) > 2:
Show all 11Show fewer
  • 4 items with a maximum possible score of 4 if the patient presented all four conditions and 0 if none were present: Tumor volume before induction chemotherapy > 500 ml, non-epithelioid histotype in the diagnostic biopsy before induction chemotherapy, CRP (C reactive protein) value > 30 mg/l before induction chemotherapy, and progressive disease after induction chemotherapy according to RECIST criteria
  • Patient with uncontrolled intercurrent illnesses that would limit the operative procedure of P/D / EPP or compliance with study requirements
  • Tinnitus impairment of more than severity grade I (slight) evaluated by the tinnitus questionnaire MiniTF12_CH (Mini Tinnitus Fragebogen 12, CH = Confoederatio Helvetica (Swiss version)), and/or restricted power of hearing until 4 kHz (kilohertz) confirmed by audiometry, unless age-related presbyacusis in a normal range confirmed by an audiologist.
  • Known alcohol and/or drug abuse at the time of screening
  • Pregnant or lactating woman

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Zurich, Division of Thoracic Surgery

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: Phase I Dose-Escalation /Phase II Monocentric Open Trial for Evaluation of Safety and Efficacy of Intracavitary Cisplatin-Fibrin Localized Chemotherapy After Pleurectomy/Decortication or Extrapleural Pneumonectomy for the Treatment of Patients With Malignant Pleural Mesothelioma

The aim is to introduce a new therapeutic method of intracavitary chemotherapy (cisplatin) combined with a fibrin carrier (Vivostat®) after pleurectomy/decortication or extrapleural pneumonectomy in a phase I and II study for Malignant Pleural Mesothelioma patients by evaluation of the safety in a dose-escalating model (phase I), and confirmation of safety and efficacy in phase II with the maximum tolerated dose in phase I.

Being tested
intracavitary cisplatin-fibrin
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intracavitary cisplatin-fibrinCombination product

    single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication

Study groups in NCT01644994
Study groupRoleWhat they receive
intracavitary cisplatin-fibrinExperimentalsingle dose local intracavitary cisplatin-fibrin application after pleurectomy/decortication
Receives: Combination Product: intracavitary cisplatin-fibrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (Safety)

    (Serious) Adverse Events \& safety blood parameters (hematology and clinical chemistry)

    Measured: during 6 weeks after surgery with local cisplatin-fibrin application

  2. Cisplatin concentration in the superficial chest wall tissue

    local cisplatin concentration in the superficial chest wall biopsy measured by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection

    Measured: 90 min after application

Secondary outcomes (9)

  1. overall survival

    time between date of treatment and time point of death or last follow-up, method of Kaplan and Meier

    Measured: up to 5 years (phase I), up to 2 years (phase II)

  2. FFR (= Freedom From Recurrence)

    time to tumor progression by CT or PET-CT/MRI, method of Kaplan and Meier

    Measured: 4, 16 weeks, then every 4 months up to 5 (phase I) / 2 years (phase II)

  3. in-treatment-field FFR (= Freedom From Recurrence)

    time to tumor progression by CT or PET-CT/MRI in the chest cavity where the investigational medicinal product was applied, method of Kaplan and Meier (PET-CT = positron emission computed tomography)

    Measured: up to 2 years (phase II)

  4. Quality of Life SF-36 (= Short Form-36)

    change from baseline in SF-36 quality of life questionnaire

    Measured: phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y

  5. Quality of Life EORTC QLQ-C15/LC13 (QLQ = Quality of Life Questionnaire, C = Cancer, LC = Lung Cancer)

    change from baseline in EORTC Lung Cancer Questionnaire QLQ-C15/LC13

    Measured: phase I: 0, 4, 8, 16 weeks and every 4w up to 5y; phase II: 0, 6, 16w and every 4w up to 2y

  6. pharmacokinetics cisplatin concentration in blood serum

    cisplatin concentration in blood serum by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection

    Measured: baseline, and 0, 2, 6, 10, 24, 48, 120 h postoperative

  7. pharmacokinetics cisplatin concentration in urine

    pharmacokinetics, cisplatin concentration in urine by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection

    Measured: baseline, collection of first 48h, day 14 postoperative

  8. TUNEL assay

    markers for apoptosis in superficial chest wall tissue

    Measured: before and 90 min after cisplatin-fibrin application

  9. PAI-1 and p21 (PAI-1 = Plasminogen Activator Inhibitor Typ 1, p21 = CDK-Inhibitor 1 = Cyclin Dependent Kinase Inhibitor 1))

    markers for senescence in superficial chest wall tissue

    Measured: before and 90 min after cisplatin-fibrin application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2019
  4. Study completionAug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label, single dose local intracavitary application of Cisplatin bound to Fibrin after surgery (removal of Tumor)
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644994
Sponsor's protocol ID
INFLuenCe - Meso
Status last verified
Sep 2021
First submitted
17 Jul 2012
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing intracavitary cisplatin-fibrin in people with Malignant Pleural Mesothelioma, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (Safety) (time frame: during 6 weeks after surgery with local cisplatin-fibrin application). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644994.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in