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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02332642
Recruitment Status : Completed
First Posted : January 7, 2015
Last Update Posted : March 7, 2017
Information provided by (Responsible Party):
Dr. Christoffer Gebhardt, Universitätsmedizin Mannheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Immuno-monitoring Other: Immuno-monitoring

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Immuno-monitoring of Patients With Metastatic Melanoma (AJCC Stadium IV) Under Chemotherapy
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Immuno-monitoring [ Time Frame: Immediate ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Metastatic melanoma patients (AJCC stage IV)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02332642

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Universitätsmedizin Mannheim, Klinik für Dermatologie, Venerologie und Allergologie
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
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Principal Investigator: Christoffer Gebhardt, M.D. Universitätsmedizin Mannheim
Principal Investigator: Jochen Utikal, M.D. Universitätsmedizin Mannheim
Additional Information:
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Responsible Party: Dr. Christoffer Gebhardt, Principal Investigator, Universitätsmedizin Mannheim Identifier: NCT02332642    
Other Study ID Numbers: 2014-624N-MA
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas