Actively Recruiting
A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2024-09-19
51
Participants Needed
1
Research Sites
624 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV Head and Neck Squamous Cell Carcinoma, Neuroendocrine Tumors, or Soft Tissue Sarcoma treated with surgery aimed at cure
- Surgical tumor specimen collected and processed according to Good Manufacturing Practice
- Disease-free status confirmed by CT or MRI within 60 days before enrollment
- Candidates for observation only after surgery, with no standard post-surgery treatment available
- Complete recovery from any surgery-related adverse events
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function including hemoglobin >10 g/dl, white blood cells ≥3000/µl, neutrophils ≥1500/µl, platelets ≥75000/µl, liver enzymes and bilirubin within specified limits, and creatinine within specified limits
- Patients aged 70 or older must have left ventricular ejection fraction ≥55%
- Compliance with highly effective contraception for patients of childbearing potential during and up to 3 months after study
- Ability and willingness to give written informed consent
You will not qualify if you...
- Presence of residual cancer after surgery (except marginal resection without evident disease)
- Surgery completed more than 90 days before enrollment
- History of other cancers within 5 years except certain skin and cervical cancers treated curatively
- History of congenital or acquired immunodeficiency or organ transplantation
- Positive serologic markers for hepatitis B, hepatitis C, HIV, or syphilis within 30 days before cell processing (except isolated hepatitis B vaccination antibodies)
- Pregnancy or nursing in female patients
- Participation in another clinical trial with investigational agents within 30 days before screening
- Active inflammatory or autoimmune disease requiring systemic steroids or immunomodulatory treatments
- Medical contraindications to leukapheresis or significant cardiac conditions in patients aged 70 or older
- Uncontrolled serious illnesses including infections, heart failure, unstable angina, arrhythmia, psychiatric illness, or social issues affecting safety or compliance
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014
Actively Recruiting
Research Team
O
Oriana Nanni, DR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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