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Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma

NCT ID: NCT01348256

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Carcinoma Hepatic Metastasis

Keywords

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colorectal carcinoma resectable hepatic metastasis adjuvant treatment dendritic cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observation

Observation after standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Dendritic cells vaccine

Adjuvant treatment with dendritic cells vaccine after standard treatment

Group Type EXPERIMENTAL

Dendritic cells vaccine

Intervention Type DRUG

Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Interventions

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Dendritic cells vaccine

Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ignacio Melero, MDPhD

Role: STUDY_CHAIR

University of Navarra

Locations

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Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Hospital de Navarra

Pamplona, Navarre, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Ignacio Melero, MD, PHD

Role: CONTACT

Phone: +34 948 255 400

Email: [email protected]

References

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Rodriguez J, Castanon E, Perez-Gracia JL, Rodriguez I, Viudez A, Alfaro C, Onate C, Perez G, Rotellar F, Inoges S, Lopez-Diaz de Cerio A, Resano L, Ponz-Sarvise M, Rodriguez-Ruiz ME, Chopitea A, Vera R, Melero I. A randomized phase II clinical trial of dendritic cell vaccination following complete resection of colon cancer liver metastasis. J Immunother Cancer. 2018 Sep 29;6(1):96. doi: 10.1186/s40425-018-0405-z.

Reference Type DERIVED
PMID: 30268156 (View on PubMed)

Other Identifiers

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2008-007795-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CD-2009-01

Identifier Type: -

Identifier Source: org_study_id