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AzTrials

Head Neck TumorsPhase 2RaC-AdNCT04166006

A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.

A Phase 2 study testing Autologous DC vaccine and Interleukin-2 in people with Head Neck Tumors and Neuroendocrine Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head/Neck tumors (H\&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autologous DC vaccine and Interleukin-2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteItaly
Study dates
12 Dec 2019to Dec 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oriana Nanni, DR contact

+39 0543739266

oriana.nanni@irst.emr.it

Italy1 site, 1 recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, FC, 47014

    Laura Ridolfi, MD, +390543739274, laura.ridolfi@irst.emr.it

    Recruiting

Other trials in Italy

About this study

Official title: 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).

Single-arm, monocentric trial to assess safety and immunological efficacy of adjuvant vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV rare cancers (In Head/Neck tumors (H\&N), NEuroendocrine Tumors (NET) and Soft Tissue Sarcomas (STS).

Read the detailed description

This is a single-arm, multi-cohort phase II study, to evaluate the immunological effectiveness and safety of adjuvant Dendritic Cell (DC) vaccination. The evaluation of immunological efficacy will be expressed as the number of patients who show enhancement of the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease (HNSCC, NET and STS). To avoid unacceptable toxicity, a formal safety analysis will be conducted after six patients have been observed (two for each disease) for at least 30 days after the third treatment cycle. If two or more patients have experienced grade 3 or higher adverse events, enrollment will be definitively stopped; differently, other 15 patients for each disease will be enrolled and evaluation of primary objectives will be done for each cohort separately (H\&N, STS and NET).

Being tested
Autologous DC vaccine, Interleukin-2
Keywords
Head Neck Tumors, Neuroendocrine Tumors, Soft Tissue Sarcoma, rare cancer, vaccination, autologous dendritic cells, adjuvant, Interleukin-2
Medical subject headings
Head and Neck Neoplasms, Neuroendocrine Tumors, Sarcoma

What participants receive

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

  • Autologous DC vaccineBiological

    7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)

  • Interleukin-2Drug

    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).

Study groups in NCT04166006
Study groupRoleWhat they receive
ExperimentalExperimental7-14×106 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.
Receives: Biological: Autologous DC vaccine; Drug: Interleukin-2

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events

    Incidence, type and severity of adverse events occurred during treatment will be reported and graded according to NCI CTCAE 5.0 criteria

    Measured: from the day of the leukapheresis up to 30 days after the last dose

  2. Immunological efficacy

    immunological efficacy will be assessed as a proportion of tumor-specific circulating immune effectors determined by IFNgamma ELISPOT

    Measured: at 4 months, after at least 3 vaccinations

Secondary outcomes (3)

  1. Overall Survival (OS)

    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.

    Measured: Up to 7 years

  2. Relapse Free Survival (RFS)

    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.

    Measured: Up to 7 years

  3. Predictive role of Delayed-Type Hypersensitivity (DTH) skin test

    Evaluation of the predictive role of a positive DTH test after at least three vaccine administrations

    Measured: Up to 7 years

Timeline

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

  1. First posted18 Nov 2019
  2. Study start12 Dec 2019
  3. Primary completionApr 2027 (estimated)
  4. Study completionDec 2031 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04166006
Sponsor's protocol ID
IRST100.42
Acronym
RaC-Ad
Status last verified
Sep 2024
First submitted
14 Nov 2019
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous DC vaccine and Interleukin-2 in people with Head Neck Tumors and Neuroendocrine Tumors, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.

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 18 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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 Italy. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Oriana Nanni, DR (+39 0543739266, oriana.nanni@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: from the day of the leukapheresis up to 30 days after the last dose). 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 NCT04166006.

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 19 Sep 2024.

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