Vaccination with autologous dendritic cells loaded with autologous tumour homogenate after curative resection for stage IV colorectal cancer: a phase II study

Phase 1

• Conditions: colorectal cancer; MedDRA version: 20.0Level: LLTClassification code 10038029Term: Rectal adenocarcinoma stage IVSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10001172Term: Adenocarcinoma of colon stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000894-11-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-20
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

- Histologically confirmed stage IV colorectal cancer surgically treated with radical intent. - The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of IRST IRCCS and must fulfil all the acceptance criteria prescribed by the GMP procedures. - The patient must be disease-free. - Age >18 years. - ECOG performance status 0 or 1. - Acceptable organ function.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

Exclusion Criteria

- Residual disease after surgery. - Relapse within 6 months since primary treatment of stage I-III colorectal cancer. - Surgery more than 60 days before study enrolment. - History of other neoplastic diseases. - History of congenital or acquired immunodeficiency. - Any positivity for the serologic markers of HBV (including at least anti-HBs antibodies and anti-HBc antibodies), HCV, HIV or Treponema pallidum. - Pregnancy or nursing. - Patients undergone surgery after preoperatory chemotherapy with a fluoropyrimidine plus oxaliplatin, unless they are not candidate for postoperatory chemotherapy with the same schedule in the opinion of the Investigator (e.g. for unacceptable toxicity) or refuse completion of the perioperatory treatment. - Participation in another clinical trial. - Any active inflammatory or autoimmune disease. - Any contraindication to leukaphaeresis.

Study & Design

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