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

Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study ID
NCT04166006
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous DC vaccine — BIOLOGICAL
    7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
  • Interleukin-2 — DRUG
    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 Details

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).

Key Dates

First listed
Nov 18, 2019
Start date
Dec 12, 2019
Status verified
Sep 2024
Primary completion
Apr 30, 2027
Completion
Dec 31, 2031

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

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 ]

Central Contacts

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