Leptomeningeal Metastasis From Malignant MelanomaPhase 1NCT01563614
A Clinical Trial to Assess the Safety & Efficacy of the Treatment of Patients With Metastasis From Malignant Melanoma - Treatment Consists of the Substances Lomustine (Capsules) & Cytarabine (Injected Into an Area Near the Spinal Cord), Accompanied by Radiotherapy of the Brain
A Phase 1 study testing Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS), Lomustine and Liposomal cytarabine in people with Leptomeningeal Metastasis From Malignant Melanoma, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis From Malignant Melanoma
- What is being tested?
- Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS), Lomustine and Liposomal cytarabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Nov 2015
- Phase
- Phase 1
- 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
- Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
- CSF flow abnormalities must be excluded
- Males or females ≥ 18 years of age
- Karnofsky Performance Status > 50%
- Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)
Who cannot join
- Unresected parenchymal brain metastases with a diameter > 3 cm
- Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
- Prior intrathecal chemotherapy
- Prior treatment with systemic cytarabine or nitrosureas
- The patient ist pregnant or breast feeding
- Severe, active co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.
- Being tested
- Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS), Lomustine, Liposomal cytarabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)Radiation
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
LomustineDrug
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Liposomal cytarabineDrug
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. Receives: Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS); Drug: Lomustine; Drug: Liposomal cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerance
The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
Measured: 30 weeks
Secondary outcomes (3)
Delay of treatments
Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
Measured: 30 weeks
Response rate
Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
Measured: 30 weeks
Progression
Neurological progression, progression free survival, overall survival.
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal Metastasis From Malignant MelanomaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Responsible party
- Principal investigator, PD Dr. Martin Glas, University Hospital, Bonn
- Investigators
- Martin Glas, PD Dr., Principal investigator, Neurologische Universitaetsklinik Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563614
- Sponsor's protocol ID
- DepoRaCe
- Status last verified
- Apr 2016
- First submitted
- 9 Mar 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
- ClinicalTrials.gov ID
- NCT01563614
- Acronym / sponsor ID
- DepoRaCe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- Mundipharma Research GmbH & Co KG
- Study start
- Mar 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Mar 2012 (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.
The purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS), Drug: Lomustine, Drug: Liposomal cytarabineBrain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal CNS metastases) with leptomeningeal metastasis as demonstrated by a positive CSF (cerebrospinal liquor) cytology AND/OR by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an MRI scan indicating the presence of meningeal tumour
- CSF flow abnormalities must be excluded
- Males or females ≥ 18 years of age
- Karnofsky Performance Status > 50%
- Adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting)
Key exclusion criteria (6 listed)
- Unresected parenchymal brain metastases with a diameter > 3 cm
- Prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)
- Prior intrathecal chemotherapy
- Prior treatment with systemic cytarabine or nitrosureas
- The patient ist pregnant or breast feeding
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 |
|---|---|---|
| Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. | Radiation | Treatment |
| LomustineBrain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. | Drug | Treatment |
| Liposomal cytarabineBrain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy. | Drug | Treatment |
Primary outcome
Safety/Tolerance
Time frame: 30 weeks
The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
3 secondary outcomes
Delay of treatments
Time frame: 30 weeks
Response rate
Time frame: 30 weeks
Progression
Time frame: 30 weeks
Results and safety
The study was stopped early (reason given: No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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.
Martin Glas, PD Dr. principal investigator
Neurologische Universitaetsklinik Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS), Lomustine and Liposomal cytarabine in people with Leptomeningeal Metastasis From Malignant Melanoma, run by University Hospital, Bonn 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Apr 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Tolerance (time frame: 30 weeks). 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 19 Apr 2016.