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
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 9
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563614

Contacts
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

Locations
Germany
Neurologische Universitaetsklinik Bonn Recruiting
Bonn, Germany, 53127
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   
Sponsors and Collaborators
University Hospital, Bonn
Mundipharma Research GmbH & Co KG
Investigators
Principal Investigator: Martin Glas, PD Dr. Neurologische Universitaetsklinik Bonn
  More Information

No publications provided

Responsible Party: PD Dr. Martin Glas, Deputy Director Division of Clinical Neurooncology Unit, University Hospital, Bonn
ClinicalTrials.gov Identifier: NCT01563614     History of Changes
Other Study ID Numbers: DepoRaCe
Study First Received: March 9, 2012
Last Updated: November 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014