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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Mundipharma Research GmbH & Co KG

Information provided by (Responsible Party):

Dr. Martin Glas, University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT01563614

First received: March 9, 2012

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2012

Last Updated Date

February 26, 2013

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety/Tolerance [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]

The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01563614 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Delay of treatments [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
Response rate [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
Progression [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Neurological progression, progression free survival, overall survival.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Leptomeningeal Metastasis From Malignant Melanoma

Intervention ^ICMJE

Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Drug: Lomustine
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
Drug: Liposomal cytarabine
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Study Arm (s)

Experimental: Treatment

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Interventions:

Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)
Drug: Lomustine
Drug: Liposomal cytarabine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2016

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01563614

Other Study ID Numbers ^ICMJE

DepoRaCe

Has Data Monitoring Committee

Responsible Party

Dr. Martin Glas, University Hospital, Bonn

Study Sponsor ^ICMJE

University Hospital, Bonn

Collaborators ^ICMJE

Mundipharma Research GmbH & Co KG

Investigators ^ICMJE

Principal Investigator:

Martin Glas, PD Dr.

Neurologische Universitaetsklinik Bonn

Information Provided By

University Hospital, Bonn

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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