Cancer vaccine containing dendritic cells for uveal melanoma patients

Phase 1

• Conditions: Patients with resected uveal melanoma showing monosomy 3, free of metastases; MedDRA version: 20.0Level: HLTClassification code 10030052Term: Ocular melanomasSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-007847-28-DE
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-12
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Resected uveal melanoma displaying monosomy 3, no evidence for metastases, WHO performance status of 0, 1 or 2, age over 18 years, negative pregnancy test, signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Evidence for metastases, seriously impaired haematological, hepatic or renal function, major serious illness, evidence for HIV-1, HIV-2, HTLV-1, HBV or HCV infection, autoimmune diseases, splenectomy or radiation therapy of the spleen, organ allografts, simultaneous chemo- or radiation therapy, simultaneous immunotherapy, pregnancy, lactation, psychiatric disorders, organic brain syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified