Actively Recruiting
A Phase II Study on Adjuvant Vaccination with Dendritic Cells Loaded with Autologous Tumor Homogenate in Resected Stage IV Rare Cancers: Head & Neck, Neuroendocrine Tumors, and Soft Tissue Sarcoma
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
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and immune response of an adjuvant vaccination using a patient's own dendritic cells loaded with tumor material after surgery for stage IV rare cancers, including Head and Neck tumors, Neuroendocrine Tumors, and Soft Tissue Sarcomas. This phase II, single-arm study aims to measure the increase in specific immune cells related to these cancers and monitor treatment safety carefully to prevent significant side effects. Participants receive treatment cycles starting with an intradermal injection of 7 to 14 million autologous dendritic cells loaded with their own tumor homogenate on day 1. This is followed by subcutaneous injections of Interleukin-2 at 3 million units daily for five days (days 3-7). Each treatment cycle lasts 28 days, with up to six cycles administered. The study includes a safety review after the first six patients complete three cycles, followed by enrollment of additional patients if safety criteria are met. During the study, participants undergo various assessments including CT scans or MRI to confirm no disease presence before starting. Researchers monitor treatment-emergent adverse events from leukapheresis day through 30 days after the last dose and measure immunological effects after at least three vaccinations. Secondary outcomes include overall survival, relapse-free survival, and skin test responses, with follow-up extending up to seven years. Participants are closely observed for safety and immune response throughout the study period.
CONDITIONS
Brief 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 & Neck Squamous Cell Carcinoma, Neuroendocrine Tumors, or Soft Tissue Sarcoma treated with surgery aiming to cure
- Autologous surgical tumor specimen collected and accepted by Good Manufactory Practice procedures
- Disease-free status confirmed by CT or MRI within 60 days before enrollment
- Candidates for observation only after surgery with no standard treatment available
- Recovery from all surgery-related adverse events
- Age 18 years or older
- ECOG performance status of 0 or 1
- Adequate organ function, including specified blood counts and liver/kidney function levels
- Patients aged 70 or older must have left ventricular ejection fraction of at least 55%
- Agreement to use highly effective contraception if of childbearing potential, from consent until three months after study end
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Presence of residual disease after surgery (except marginal resection without clinical residual disease)
- Surgery completed more than 90 days before enrollment
- History of other cancers within 5 years except certain skin and cervical carcinomas treated with curative surgery
- History of congenital or acquired immunodeficiency or organ transplantation
- Positive serologic markers for hepatitis B, hepatitis C, HIV, or Treponema pallidum (except isolated HBV vaccination markers)
- Pregnancy or nursing
- Participation in another investigational trial within 30 days prior to screening
- Active inflammatory or autoimmune diseases requiring systemic immunosuppressive treatment
- Contraindications to leukapheresis or clinically relevant cardiac conditions in patients 70 or older
- Uncontrolled serious illnesses including active infections, heart failure, unstable angina, arrhythmias, or psychiatric/social conditions impacting safety
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles, each cycle 28 days
Participants receive up to six cycles of autologous dendritic cell vaccination followed by Interleukin-2 injections. Each treatment cycle lasts 28 days and includes 1 day of dendritic cell vaccine injection and 5 days of daily Interleukin-2 injections.
1 visit per cycle for vaccine injection and daily injections of Interleukin-2 for 5 days per cycle
Duration - Up to 7 years
Participants are monitored for safety and immunological efficacy, including assessment of treatment-emergent adverse events and immune response up to 30 days after the last dose and long-term survival outcomes up to 7 years.
Periodic visits over 7 years for survival and immune monitoring
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here