Back to resultsA 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
Primary Purpose
Leptomeningeal Metastasis From Malignant Melanoma
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
Lomustine
Liposomal cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Leptomeningeal Metastasis From Malignant Melanoma
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Neurologische Universitaetsklinik Bonn
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Outcomes
Primary Outcome Measures
Safety/Tolerance
The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
Secondary Outcome Measures
Delay of treatments
Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
Response rate
Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
Progression
Neurological progression, progression free survival, overall survival.
Full Information
NCT ID
NCT01563614
First Posted
March 9, 2012
Last Updated
April 18, 2016
Sponsor
University Hospital, Bonn
Collaborators
Mundipharma Research GmbH & Co KG
1. Study Identification
Unique Protocol Identification Number
NCT01563614
Brief Title
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
Official Title
Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn
Collaborators
Mundipharma Research GmbH & Co KG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leptomeningeal Metastasis From Malignant Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
Intervention Description
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Lomustine
Intervention Description
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Liposomal cytarabine
Intervention Description
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Primary Outcome Measure Information:
Title
Safety/Tolerance
Description
The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Delay of treatments
Description
Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
Time Frame
30 weeks
Title
Response rate
Description
Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
Time Frame
30 weeks
Title
Progression
Description
Neurological progression, progression free survival, overall survival.
Time Frame
30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Glas, PD Dr.
Organizational Affiliation
Neurologische Universitaetsklinik Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurologische Universitaetsklinik Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
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
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