A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homoge… (NCT04166006) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.
Italy51 participantsStarted 2019-12-12
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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.
✕
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: from the day of the leukapheresis up to 30 days after the last dose
2
Immunological efficacy
Timeframe: at 4 months, after at least 3 vaccinations
Trial details
NCT IDNCT04166006
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
. 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.
✕. 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.