Ocular MelanomaPhase 2NCT00168870
Study of Metastatic Ocular Melanoma
A Phase 2 study testing Gemcitabine and Treosulfan in people with Ocular Melanoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Melanoma
- What is being tested?
- Gemcitabine and Treosulfan
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic ocular melanoma
Who cannot join
- Prior treatment with chemotherapy
- Active 2nd malignancy
- Cerebral metastasis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hematology & Oncology Charité CBF Berlin
Berlin, State of Berlin, 12203
Ulrich Keilholz, MD, +49-30-8445-3596, ulrich.keilholz@charite.de
Alexander Schmittel, MD, +49-30-8445-3090, alexander.schmittel@charite.de
About this study
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
This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.
Read the detailed description
Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.
- Conditions
- Ocular Melanoma
- Being tested
- Gemcitabine, Treosulfan
- Keywords
- metastatic ocular melanoma
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
TreosulfanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Secondary outcomes (1)
Time to progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular MelanomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Ulrich Keilholz, MD, Principal investigator, Charité Campus Benjamin Franklin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00168870
- Sponsor's protocol ID
- Haema CBF AHM UK/AS 04
- Status last verified
- Sep 2006
- First submitted
- 9 Sep 2005
- Last updated
- 31 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00168870
- Acronym / sponsor ID
- Haema CBF AHM UK/AS 04
- Conditions
- Ocular Melanoma
- Keywords
- metastatic ocular melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Feb 2003
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Metastatic ocular melanoma
Key exclusion criteria (3 listed)
- Prior treatment with chemotherapy
- Active 2nd malignancy
- Cerebral metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine | Drug | – |
| Treosulfan | Drug | – |
Primary outcome
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
1 secondary outcome
Time to progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2007.
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A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Keilholz, MD principal investigator
Charité Campus Benjamin Franklin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine and Treosulfan in people with Ocular Melanoma, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich Keilholz, MD (+49-30-8445-3596, ulrich.keilholz@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2007.