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Denosumab in Ebv related nasopharyngeal carcinoma (Npc) as a model for rank-mediated immunologic modulation of virus-related tumours – DERN study

Studio Clinico

Patologia: Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Linee di trattamento: Prima linea

Criteri di inclusione: 

1. EBV related nasopharyngeal cancer1. EBV related nasopharyngeal cancer
2. Detectable and quantifiable plasmatic EBV DNA 
3. Recurrent and/or metastatic disease not suitable for curative treatment
4. PS < 2
5. Suitable for polychemotherapy
6. Age ≥ 18 years
7. Informed consent signed
8. Subject has adequate organ functions, evidenced by the following:
    a. AST (SGOT), ALT (SGPT) ≤ 2.5 x upper limit of normal range (ULN), or ≤ 5 x ULN range if liver metastasis present.
    b. Total bilirubin ≤ 1.5 x ULN.
    c. creatinine clearance 24/h > 50 mL/min 
    d. Total serum calcium > 8.8 mg/dL
    e. Absolute neutrophil count ≥ 1.5 x 10*9 cells/L
    f. Platelets ≥ 100 x 10*9 cells/L
    g. Haemoglobin ≥ 9 g/dL
9. If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilisation, sexual abstinence) for the study duration and 5 months post-dosing.
10. Subject understands and voluntarily signs an ICF prior to any study-related assessments/procedures are conducted.
11. Subject is able to adhere to the study visit schedule and other protocol requirements.

Criteri di esclusione: 

1. Having received 1 or more chemotherapy line for recurrent/metastatic disease
2. Any residual CTCAE grade ≥ 2 toxicity
3. Subject has any other malignancy within 3 years prior to randomization, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or non-melanoma skin cancer (all treatment of which should have been completed 6 months prior to enrolment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer T1a, Gleason < 7, PSA <10 ng/ml.
4. Subject has had radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting IP, and/or from whom ≥ 30% of the bone marrow was irradiated.
5. Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry.
6. Chronic systemic immunosuppressive therapy that cannot be interrupted during treatment study.
7. Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
8. Subject has a known or suspected hypersensitivity to study drugs.
9. Subject is pregnant or breast feeding.
10. Subject is receiving prohibited medication as per section 7.4.2 and suspension of such treatment is considered unsafe.
11. Subject has history of prior or current osteonecrosis of the jaw (ONJ).
12. Subject has history of prior irradiation to the mandible, specified as:
Dose constraints to the mandible: Dmax = 70 Gy, V50 = 62 Gy and V60 = 20 GyMandible should be contoured as whole organ, with alveolar bone, excluding teeth.
13. Subject has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, contraindicate subject participation in the clinical study.

Trattamento sperimentale: 

Arm A: Denosumab 120 mg sc on day -15, -8 and day 1, followed by Denosumab 120 mg sc q4wks + platinum based drugs q3wks + Gemcitabine 1250 mg/sm day 1,8 q3wks for 6 cycles. Denosumab 120 mg sc q4wks will continue for 12 months since chemotherapy end.

Trattamento di controllo: 

Arm B: platinum based drugs q3wks + Gemcitabine 1250 mg/sm day 1,8 q3wks for 6 cycles.

Obiettivi primari dello studio: 

To evaluate the impact of denosumab on a recognized viral surrogate marker of tumour response in nasopharyngeal cancer.

Obiettivi secondari dello studio: 

- To evaluate the clinical activity of denosumab and chemotherapy vs chemotherapy alone in terms of the improvement in PFS of denosumab-treated patients.
- To assess the safety of denosumab when added to chemotherapy in first line treatment of recurrent/metastatic NPC
- To evaluate the immunologic effects of denosumab therapy in a population of patients at first line chemotherapy for recurrent/metastatic nasopharyngeal cancer.

Centri partecipanti

Nord Italia

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

 

Azienda Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

 

Azienda Ospedaliera S. Croce e Carle di Cuneo
Via Michele Coppino 26 - 12100 Cuneo - CN

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

 

A.O.U. “ Maggiore della Carità”
Corso Mazzini 18 - 28100 Novara - NO

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

 

IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV

 

AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO

 

AOUI Verona - Borgo Roma
Piazzale Ludovico Antonio Scuro 10 - 37134 Verona - VR

 

Centro Italia

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI

 

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

 

Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM

 

Sud Italia e isole

Ospedale Oncologico - Businco ASL Cagliari
Via Edward Jenner 1 - 09121 Cagliari - CA

 

IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG

 

Presidio Ospedaliero Vito Fazzi Asl Lecce
Piazzetta F. Muratore - 73100 Lecce - LE

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

 

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-005017-31

Data di inserimento: 07.09.2020

Promotore

Fondazione GONO (Gruppo Oncologico del Nord-Ovest)

CRO

na

Principal Investigator ITALIA

Università degli Studi di Brescia ASST degli Spedali Civili di Brescia

Riferimento: Prof. Paolo Bossi

Telefono: 03039951

Email: paolo.bossi@unibs.it

Localita: Brescia

 

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