Study of Metastatic Ocular Melanoma

This study is currently recruiting participants.

Verified by Charite University, Berlin, Germany, September 2006

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00168870

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 II

MedlinePlus related topics: Melanoma

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Treosulfan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic ocular melanoma

Exclusion Criteria:

Prior treatment with chemotherapy
Active 2nd malignancy
Cerebral metastasis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	Haema CBF AHM UK/AS 04
Study First Received:	September 9, 2005
Last Updated:	August 30, 2007
ClinicalTrials.gov Identifier:	NCT00168870
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

metastatic ocular melanoma

Study placed in the following topic categories:

Ocular melanoma
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Treosulfan
Gemcitabine
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on January 13, 2009