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Study of Metastatic Ocular Melanoma

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: NCT00168870
Recruitment Status : Unknown
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : August 31, 2007
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Condition or disease Intervention/treatment Phase
Ocular Melanoma Drug: Gemcitabine Drug: Treosulfan Phase 2

Detailed Description:
Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study to Compare a Combination Therapy With Gemcitabine and Treosulfan Versus a Monotherapy as First-Line Chemotherapy for Patients With Metastatic Ocular Melanoma
Study Start Date : February 2003

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Gemcitabine

Primary Outcome Measures :
  1. Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Secondary Outcome Measures :
  1. Time to progression

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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic ocular melanoma

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Active 2nd malignancy
  • Cerebral metastasis

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): NCT00168870

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Contact: Ulrich Keilholz, MD +49-30-8445-3596
Contact: Alexander Schmittel, MD +49-30-8445-3090

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Hematology & Oncology Charité CBF Berlin Recruiting
Berlin, Germany, 12203
Contact: Ulrich Keilholz, MD    +49-30-8445-3596   
Contact: Alexander Schmittel, MD    +49-30-8445-3090   
Principal Investigator: Ulrich Keilholz, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin Berlin
Layout table for additonal information Identifier: NCT00168870    
Other Study ID Numbers: Haema CBF AHM UK/AS 04
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 31, 2007
Last Verified: September 2006
Keywords provided by Charite University, Berlin, Germany:
metastatic ocular melanoma
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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents