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

NCT ID: NCT01563614

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-11-30

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.

Conditions

Leptomeningeal Metastasis From Malignant Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Lomustine

Intervention Type: DRUG

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Liposomal cytarabine

Intervention Type: DRUG

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Interventions

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

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Intervention Type: RADIATION

Lomustine

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Intervention Type: DRUG

Liposomal cytarabine

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Research GmbH & Co KG

INDUSTRY

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Martin Glas

Deputy Director Division of Clinical Neurooncology Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Glas, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Neurologische Universitaetsklinik Bonn

Locations

Neurologische Universitaetsklinik Bonn

Bonn, , Germany

Countries

Germany

Other Identifiers

DepoRaCe

Identifier Type: -

Identifier Source: org_study_id