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

• ClinicalTrials.gov Identifier: NCT01563614
• Recruitment Status: Terminated
• First Posted: March 27, 2012
• Last Update Posted: April 19, 2016
• Sponsor: University Hospital, Bonn
• Collaborator: Mundipharma Research GmbH & Co KG
• Information provided by (Responsible Party): PD Dr. Martin Glas, University Hospital, Bonn

Tracking Information

• First Submitted Date: March 9, 2012
• First Posted Date: March 27, 2012
• Last Update Posted Date: April 19, 2016
• Study Start Date: March 2012
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leptomeningeal Metastasis From Malignant Melanoma

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 18, 2016): 1
• Original Estimated Enrollment (submitted: March 22, 2012): 9
• Actual Study Completion Date: November 2015
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01563614
• Other Study ID Numbers: DepoRaCe
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: PD Dr. Martin Glas, University Hospital, Bonn
• Study Sponsor: University Hospital, Bonn
• Collaborators: Mundipharma Research GmbH & Co KG

Investigators

• Principal Investigator: Martin Glas, PD Dr.; Neurologische Universitaetsklinik Bonn

• PRS Account: University Hospital, Bonn
• Verification Date: April 2016