NCT00168870

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

August 31, 2007

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

August 30, 2007

Conditions

Ocular Melanoma

Keywords

metastatic ocular melanoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Time to progression

Interventions

GemcitabineDRUG
TreosulfanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic ocular melanoma

You may not qualify if:

  • Prior treatment with chemotherapy
  • Active 2nd malignancy
  • Cerebral metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology & Oncology Charité CBF Berlin

Berlin, State of Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Gemcitabinetreosulfan

Condition Hierarchy (Ancestors)

MelanomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ulrich Keilholz, MD

    Charité Campus Benjamin Franklin Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrich Keilholz, MD

CONTACT

+49-30-8445-3596ulrich.keilholz@charite.de

Alexander Schmittel, MD

CONTACT

+49-30-8445-3090alexander.schmittel@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

February 1, 2003

Last Updated

August 31, 2007

Record last verified: 2006-09

Locations

DE(1)