MedTrace Logo

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

NCT01563614 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-04-19

No results posted yet for this study

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.

Conditions

  • Leptomeningeal Metastasis From Malignant Melanoma

Interventions

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.

Sponsors & Collaborators

  • Mundipharma Research GmbH & Co KG

    collaborator INDUSTRY

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Martin Glas, PD Dr. · Neurologische Universitaetsklinik Bonn

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563614 on ClinicalTrials.gov