Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy

NCT ID: NCT02332642

Last Updated: 2017-03-07

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

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-12-31

Brief Summary

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This pilot clinical trial aims at evaluating immuno-modulating effects of palliative treatment with specifically dosed standard chemotherapeutics in patients with metastatic melanoma (AJCC stage IV) by assessing myeloid-derived suppressor cells' (MDSCs) count and activity.

Detailed Description

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Conditions

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Immuno-monitoring

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Interventions

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Immuno-monitoring

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* histologically defined metastatic melanoma patients (AJCC stage IV)
* aged 18 to 80 years
* at least one prior systemic anti-melanoma therapy; if BRAFV600 positive, at least one prior BRAFi therapy

Exclusion Criteria

* therapy-naive patients
* any contra-indications for (specific) systemic chemotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christoffer Gebhardt

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoffer Gebhardt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Jochen Utikal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Universitätsmedizin Mannheim

Locations

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Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie

Mannheim, , Germany

Site Status

Countries

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Germany

Related Links

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Other Identifiers

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2014-624N-MA

Identifier Type: -

Identifier Source: org_study_id

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