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

April 18, 2016 updated by: PD Dr. Martin Glas, University Hospital, Bonn

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Neurologische Universitaetsklinik Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay of treatments
Time Frame: 30 weeks
Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
30 weeks
Response rate
Time Frame: 30 weeks
Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
30 weeks
Progression
Time Frame: 30 weeks
Neurological progression, progression free survival, overall survival.
30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Collaborators

Mundipharma Research GmbH & Co KG

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DepoRaCe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leptomeningeal Metastasis From Malignant Melanoma

Clinical Trials on Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe