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Study of Metastatic Ocular Melanoma

NCT ID: NCT00168870

Last Updated: 2007-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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

Detailed Description

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

Conditions

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Ocular Melanoma

Keywords

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metastatic ocular melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gemcitabine

Intervention Type DRUG

Treosulfan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Metastatic ocular melanoma

Exclusion Criteria

* Prior treatment with chemotherapy
* Active 2nd malignancy
* Cerebral metastasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Principal Investigators

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Ulrich Keilholz, MD

Role: PRINCIPAL_INVESTIGATOR

Charité Campus Benjamin Franklin Berlin

Locations

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Hematology & Oncology Charité CBF Berlin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ulrich Keilholz, MD

Role: CONTACT

Phone: +49-30-8445-3596

Email: [email protected]

Alexander Schmittel, MD

Role: CONTACT

Phone: +49-30-8445-3090

Email: [email protected]

Facility Contacts

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Ulrich Keilholz, MD

Role: primary

Alexander Schmittel, MD

Role: backup

Other Identifiers

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Haema CBF AHM UK/AS 04

Identifier Type: -

Identifier Source: org_study_id