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Study of Metastatic Ocular Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168870
First Posted: September 15, 2005
Last Update Posted: August 31, 2007
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.
Information provided by:
Charite University, Berlin, Germany
  Purpose
This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Condition Intervention Phase
Ocular Melanoma Drug: Gemcitabine Drug: Treosulfan Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

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

Secondary Outcome Measures:
  • Time to progression

Estimated Enrollment: 48
Study Start Date: February 2003
Detailed Description:
Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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
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
Principal Investigator: Ulrich Keilholz, MD Charité Campus Benjamin Franklin Berlin
  More Information

ClinicalTrials.gov Identifier: NCT00168870     History of Changes
Other Study ID Numbers: Haema CBF AHM UK/AS 04
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: August 31, 2007
Last Verified: September 2006

Keywords provided by Charite University, Berlin, Germany:
metastatic ocular melanoma

Additional relevant MeSH terms:
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