Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date April 19, 2016
Study Start Date  ICMJE March 2012
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Delay of treatments [ Time Frame: 30 weeks ]
    Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
  • Response rate [ Time Frame: 30 weeks ]
    Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
  • Progression [ Time Frame: 30 weeks ]
    Neurological progression, progression free survival, overall survival.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE 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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
9
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01563614
Other Study ID Numbers  ICMJE DepoRaCe
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PD 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
PRS Account University Hospital, Bonn
Verification Date April 2016

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