Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01348256
Other study ID # CD-2009-01
Secondary ID 2008-007795-23
Status Recruiting
Phase Phase 2
First received May 3, 2011
Last updated October 23, 2017
Start date November 2010
Est. completion date December 2018

Study information

Verified date October 2017
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact Ignacio Melero, MD, PHD
Phone +34 948 255 400
Email imelero@unav.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 58
Est. completion date December 2018
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age over 18 years.

2. Confirmed diagnosis of colorectal cancer with hepatic metastasis, amenable for surgical treatment.

3. Capacity of understanding and signing the informed consent and to undergo the study procedures

4. Availability of tumor tissue, for maturing dendritic cells

5. Adequate renal, hepatic and bone marrow function

Exclusion Criteria:

1. Clinically relevant diseases or infections.

2. Concurrent participation in other clinical trial or administration or other antitumoral treatment

3. Concurrent cancer, with the exceptions allowed by the principal investigator (PI).

4. Pregnant or breast feeding women

5. Immunosuppressant treatment

Study Design


Intervention

Drug:
Dendritic cells vaccine
Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Locations

Country Name City State
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital de Navarra Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free survival Progression free survival at 2 years
Secondary Overall survival 2 years
See also
  Status Clinical Trial Phase
Completed NCT04444232 - Cancer Communication Within Hispanic Social Networks N/A
Recruiting NCT06233253 - Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy N/A
Recruiting NCT05799820 - QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC Phase 2
Recruiting NCT04666727 - Role of Diet on the Microbiome of the Digestive System
Recruiting NCT04767984 - Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis Phase 2
Recruiting NCT02376452 - Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients Phase 2
Completed NCT02254486 - Multicenter Randomized Parallel Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability of NER1006 Versus Trisulfate Solution Using 2-Day Split-Dosing Regimen in Adults Phase 3
Completed NCT01486251 - Assessment of Tumor Vascular Effects of Axitinib With Dynamic Ultrasonography in Patients With Metastatic Colorectal Cancer N/A
Terminated NCT01233544 - Radiofrequency Ablation Versus Stereotactic Radiotherapy in Colorectal Liver Metastases Phase 3
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed NCT00704600 - Nelfinavir, a Phase I/Phase II Rectal Cancer Study Phase 1/Phase 2
Completed NCT00485316 - Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma Phase 3
Recruiting NCT04430738 - Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers Phase 1/Phase 2
Terminated NCT02669914 - MEDI4736 (Durvalumab) in Patients With Brain Metastasis From Epithelial-derived Tumors Phase 2
Completed NCT05022511 - Three Birds With One Stone N/A
Completed NCT04607291 - Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening Phase 1
Not yet recruiting NCT03969784 - Microparticles in Peritoneal Carcinomatosis of Colorectal Origin N/A
Not yet recruiting NCT05630794 - Testing ONC201 to Prevent Colorectal Cancer Phase 1
Terminated NCT05291988 - A Multilevel Approach for Improvement in Screening of Colorectal Cancer in Rural Communities, The Screen to Save Trial N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2