Immune-ECT - Immune system activation by electrochemotherapy: hypothesis validating within a prospective study.

Studio Clinico

Patologia: Melanoma, Neoplasie del polmone, Tumori cutanei non melanoma, Tumori del rene, Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. Age ≥ 18 years.
2. Signed written informed consent.
3. Histologically confirmed:
    a) squamous cell cancer of head and neck;
    b) melanoma;
    c) non-melanoma skin cancer;
    d) lung cancer;
    e) kidney cancer.
4. Disease not amenable to curative intent therapy
5. At least one lesion suitable for treatment with ECT and clinical indication to perform this technique
6. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
7. Adequate organ function as defined by: * absolute neutrophil count ≥ 1000
* hemoglobin ≥ 8.0 gram/deciliter (g/dL)
* platelet count ≥ 75,000* total bilirubin ≤1.5 times institution's upper limit of normal
* AST and ALT ≤ 2.5 times institutional upper limit of normal* albumin ≥ 2.0 g/dL
* serum creatinine ≤ 1.5 times institutional upper limit of normal or creatinine clearance ≥ 30 milliliters per minute (mL/min).

Criteri di esclusione: 

1. Any concurrent chemotherapy, Investigational Product, biologic, or hormonal therapy for cancer treatment. Prior chemotherapy must be completed at least 21 days before Study Day 1.
Previous or ongoing systemic immunotherapy with PD 1/PD L1 and/or CTLA4 inhibitors is permitted.
2. Palliative radiotherapy to metastatic lesion(s) is permitted if performed at least 14 days before ECT, provided there is at least one measurable lesion that has not been irradiated.
3. Received major surgery within 14 days of Study Day 1; feeding tube placement (radiological or endoscopic gastrostomy) is allowed.
4. Chronic need for systemic steroid therapy (>10 mg prednisone daily, or steroid equivalent) or any other form of immunosuppressive therapy.
5. Known allergy or hypersensitivity to Investigational Product
6. Active infection requiring systemic therapy.
7. History or current evidence of any condition that, in the opinion of the treating investigator, might interfere with the subject's participation for the full duration of the trial.
8. Pregnant or breastfeeding.
9. Furthermore, in patients that have had allergic reaction to bleomycin, electrochemotherapy is contraindicated to the corresponding drug.

Numero di pazienti previsti: 

30

Schema di trattamento: 

ECT treatment will be performed according to SOP (Standar Operating Procedures) guideline. Body surface of patients will be calculated before Bleomycin administration at a dosage of 15.000 IU/m2 bolus. All accessible lesions will be treated by intravenous chemotherapy, followed by needle electroporation and application of a pulse electrical field. Both local and systemic anesthesia is allowed.

Trattamento sperimentale: 

Electrochemotherapy (ECT)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

The primary endpoint is to evaluate the change in circulating immune population in patients treated with ECT.

Obiettivi secondari dello studio: 

Secondary objectives include:
- Evaluation of changes in the remaining circulating immune population (not included in the primary endpoint) in patients treated with ECT.
- Evaluation of the whole safety of the treatment
- Evaluation of local response to ECT in the short-period
- Assessment of survival and response (local and systemic)
- Analysis of the response to further systemic treatment(s) performed according to clinical practice.

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NA

Data di inserimento: 12.05.2022

Promotore

ASST Spedali Civili di Brescia

Principal Investigator ITALIA

ASST Spedali Civili di Brescia

Riferimento: Prof. Paolo Bossi

Telefono: 0303996320

Email: paolo.bossi@unibs.it

Localita: Brescia