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

University Hospital Bonn (UKB)

Status and phase

Terminated

Phase 1

Conditions

Leptomeningeal Metastasis From Malignant Melanoma

Treatments

Drug: Lomustine

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

Drug: Liposomal cytarabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01563614

DepoRaCe

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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