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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bonn
Sponsor:
Collaborator:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
PD Dr. Martin Glas, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01563614
First received: March 9, 2012
Last updated: November 13, 2013
Last verified: November 2013

March 9, 2012
November 13, 2013
March 2012
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01563614 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leptomeningeal Metastasis From Malignant Melanoma
  • 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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9
March 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Martin Glas, PD Dr. 49 228 287 ext 19887 martin.glas@ukb.uni-bonn.de
Contact: Moritz Stuplich, Dr. 49 228 287 ext 15712 moritz.stuplich@ukb.uni-bonn.de
Germany
 
NCT01563614
DepoRaCe
No
PD Dr. Martin Glas, University Hospital, Bonn
University Hospital, Bonn
Mundipharma Research GmbH & Co KG
Principal Investigator: Martin Glas, PD Dr. Neurologische Universitaetsklinik Bonn
University Hospital, Bonn
November 2013

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