- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04166006
A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers. (RaC-Ad)
A Phase II Study on Adjuvant Vaccination With Dendritic Cells Loaded With Autologous Tumor Homogenate in Resected Stage IV Rare Cancers: Head&Neck (H&N), Neuroendocrine Tumors (NET) and Soft Tissue Sarcoma (STS).
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Oriana Nanni, DR
- Telefonnummer: +390543739266
- E-Mail: oriana.nanni@irst.emr.it
Studienorte
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FC
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Meldola, FC, Italien, 47014
- Rekrutierung
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
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Kontakt:
- Laura Ridolfi, MD
- Telefonnummer: +390543739274
- E-Mail: laura.ridolfi@irst.emr.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Patients must have histologically confirmed stage IV Head&Neck Squamous Cell Carcinoma (HNSCC), NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS) surgically treated with radical intent.
- The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab and must fulfil all the acceptance criteria prescribed by the Good Manufactory Practice (GMP) procedures.
- The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.
- Patients disease-free candidates for only observation as per clinical practice (no standard treatment is available after surgery)
- The patient must have recovered from all the adverse events related to previous surgery.
- Age ≥18 years.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1.
Patient must have acceptable organ function, defined as:
- Haemoglobin >10 g/dl
- White blood cells ≥3000/μl.
- Absolute neutrophil count ≥1500/μl.
- Platelets≥75000/μl.
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 times the upper institutional reference level.
- Total bilirubin <1.5 times the upper institutional reference level.
- Serum creatinine <1.5 times the upper institutional reference level.
- Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography.
- Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of <1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if patients' lifestyle guarantees his/her strict compliance with this prescription in the judgement of the Investigator.
- The patient is willing and able to give written informed consent for the study.
Exclusion Criteria:
- Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- Patient who completed surgery more than 90 days before study enrolment.
- History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery.
- History of congenital or acquired immunodeficiency, including history of organ transplantation.
Any positivity for the serologic markers of hepatitis B virus (HBV) (including at least anti- Hepatitis B surface antibodies (HBs) and hepatitis B core (HBc) antibodies, hepatitis C virus (HCV), HIV or Treponema pallidum. The serologic tests must have been performed within 30 days before any GMP-regulated activity (i.e. surgical resection and leukapheresis). The sole positivity for antibodies against the HBV surface antigen (i.e.
with all other HBV markers negative) is indicative of previous HBV vaccination and therefore is acceptable.
- Female patients who are pregnant or nursing.
- Participation in another clinical trial with any investigational agent within 30 days prior to study screening.
- Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator.
- Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukapheresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic.
- Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations potentially impacting patient safety and compliance in the opinion of the Investigator.
- Refusal of giving written informed consent.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Experimental
7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1), followed by Interleukin (IL) - 2 (IL-2), at a dose of 3 Million Units (MU), given by subcutaneous injection daily for five days (days 3-7). This constitutes a treatment cycle. Treatment cycles are repeated every 28 days up to a maximum of six cycles. |
7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
Autologous DC vaccine is followed by IL-2, at a dose of 3 MU, given by subcutaneous injection daily for five days (days 3-7).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Incidence of Treatment-Emergent Adverse Events
Zeitfenster: from the day of the leukapheresis up to 30 days after the last dose
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Incidence, type and severity of adverse events occurred during treatment will be reported and graded according to NCI CTCAE 5.0 criteria
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from the day of the leukapheresis up to 30 days after the last dose
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Immunological efficacy
Zeitfenster: at 4 months, after at least 3 vaccinations
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immunological efficacy will be assessed as a proportion of tumor-specific circulating immune effectors determined by IFNgamma ELISPOT
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at 4 months, after at least 3 vaccinations
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Survival (OS)
Zeitfenster: Up to 7 years
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OS is the time from registration to the time of death from any cause.
Subjects who are alive at the time of the final analysis or who have become lost to follow-up will be censored at their last known alive date.
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Up to 7 years
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Relapse Free Survival (RFS)
Zeitfenster: Up to 7 years
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RFS is the time from registration to the first date of documented progression (or death for any causes).
Subject without progression will be censored at their last tumor assessment date.
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Up to 7 years
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Predictive role of Delayed-Type Hypersensitivity (DTH) skin test
Zeitfenster: Up to 7 years
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Evaluation of the predictive role of a positive DTH test after at least three vaccine administrations
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Up to 7 years
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Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Laura Ridolfi, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen, Binde- und Weichgewebe
- Neubildungen nach histologischem Typ
- Neubildungen nach Standort
- Neuroektodermale Tumoren
- Neoplasmen, Keimzelle und Embryonal
- Neubildungen, Nervengewebe
- Neubildungen
- Sarkom
- Kopf-Hals-Neubildungen
- Neuroendokrine Tumoren
- Physiologische Wirkungen von Arzneimitteln
- Agenten des peripheren Nervensystems
- Analgetika
- Agenten des sensorischen Systems
- Analgetika, nicht narkotisch
- Antineoplastische Mittel
- Interleukin-2
Andere Studien-ID-Nummern
- IRST100.42
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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