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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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ClinicalTrials.gov Identifier: NCT01563614
Recruitment Status : Terminated (No patients can be recruited for this trial anymore due to other therapeutical approaches that became available.)
First Posted : March 27, 2012
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
PD Dr. Martin Glas, University Hospital, Bonn

Study Description
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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.

Condition or disease Intervention/treatment Phase
Leptomeningeal Metastasis From Malignant Melanoma Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS) Drug: Lomustine Drug: Liposomal cytarabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Delay of treatments [ Time Frame: 30 weeks ]
    Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).

  2. Response rate [ Time Frame: 30 weeks ]
    Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.

  3. Progression [ Time Frame: 30 weeks ]
    Neurological progression, progression free survival, overall survival.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563614


Locations
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Germany
Neurologische Universitaetsklinik Bonn
Bonn, Germany, 53127
Sponsors and Collaborators
University Hospital, Bonn
Mundipharma Research GmbH & Co KG
Investigators
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Principal Investigator: Martin Glas, PD Dr. Neurologische Universitaetsklinik Bonn
More Information
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Responsible Party: PD Dr. Martin Glas, Deputy Director Division of Clinical Neurooncology Unit, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01563614    
Other Study ID Numbers: DepoRaCe
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Melanoma
Neoplasm Metastasis
Meningeal Carcinomatosis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
 Neoplasms by Site
Nervous System Diseases
Cytarabine
Lomustine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents