Study of Metastatic Ocular Melanoma | NCT00168870

Studies
Study of Metastatic Ocular Melanoma

NCT00168870

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Aug 31, 2007Estimated

Enrollment

48Estimated

Phase

Phase 2

Conditions

Ocular Melanoma

Interventions

Gemcitabine
Treosulfan

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2007

Last Update Posted Date

Aug 31, 2007Estimated

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Secondary Outcomes

Measure	Description	Time Frame
Time to progression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Metastatic ocular melanoma

Exclusion Criteria:

Prior treatment with chemotherapy
Active 2nd malignancy
Cerebral metastasis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ulrich Keilholz, MD	Contact	+49-30-8445-3596		ulrich.keilholz@charite.de
Alexander Schmittel, MD	Contact	+49-30-8445-3090		alexander.schmittel@charite.de

Overall Officials

Name	Affiliation	Role
Ulrich Keilholz, MD	Charité Campus Benjamin Franklin Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hematology & Oncology Charité CBF Berlin	Recruiting	Berlin	State of Berlin	12203	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000098943	Uveal Melanoma

Ancestor Terms

ID	Term
D008545	Melanoma
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
C018404	treosulfan

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug
Treosulfan	Drug