Study of Metastatic Ocular Melanoma

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00168870
• Collaborator: (none)
• Enrollment: 48
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ocular Melanoma	Drug: Gemcitabine; Drug: Treosulfan	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2003

Outcome Measures

Primary Outcome Measures

1. Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria []

Secondary Outcome Measures

1. Time to progression []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Metastatic ocular melanoma

Exclusion Criteria:

• Prior treatment with chemotherapy

• Active 2nd malignancy

• Cerebral metastasis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematology & Oncology Charité CBF Berlin	Berlin		Germany	12203

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Ulrich Keilholz, MD, Charité Campus Benjamin Franklin Berlin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00168870
• Other Study ID Numbers: Haema CBF AHM UK/AS 04
• First Posted: Sep 15, 2005
• Last Update Posted: Aug 31, 2007
• Last Verified: Sep 1, 2006

• Keywords provided by , ,: metastatic ocular melanoma
• Additional relevant MeSH terms: Melanoma; Gemcitabine; Treosulfan

Study Results

No Results Posted as of Aug 31, 2007