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Study of Metastatic Ocular Melanoma

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Study Description
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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.
Study Design
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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

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

Secondary Outcome Measures :
  1. Time to progression

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic ocular melanoma

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Active 2nd malignancy
  • Cerebral metastasis
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00168870


Contacts
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Contact: Ulrich Keilholz, MD +49-30-8445-3596 ulrich.keilholz@charite.de
Contact: Alexander Schmittel, MD +49-30-8445-3090 alexander.schmittel@charite.de

Locations
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Germany
Hematology & Oncology Charité CBF Berlin Recruiting
Berlin, Germany, 12203
Contact: Ulrich Keilholz, MD    +49-30-8445-3596    ulrich.keilholz@charite.de   
Contact: Alexander Schmittel, MD    +49-30-8445-3090    alexander.schmittel@charite.de   
Principal Investigator: Ulrich Keilholz, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin Berlin
More Information
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ClinicalTrials.gov 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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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Gemcitabine
Treosulfan
Antimetabolites, Antineoplastic
 Antimetabolites
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