Study of Metastatic Ocular Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00168870
First received: September 9, 2005
Last updated: August 30, 2007
Last verified: September 2006
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
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, see Learn About Clinical Studies.

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

No publications provided

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

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 19, 2014