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Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Leptomeningeal Metastasis From Malignant Melanoma

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Trial Information

Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety/Tolerance

Outcome Description:

The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.

Outcome Time Frame:

30 weeks

Safety Issue:

Yes

Principal Investigator

Martin Glas, PD Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Neurologische Universitaetsklinik Bonn

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

DepoRaCe

NCT ID:

NCT01563614

Start Date:

March 2012

Completion Date:

March 2016

Related Keywords:

  • Leptomeningeal Metastasis From Malignant Melanoma
  • Melanoma
  • Neoplasm Metastasis
  • Meningeal Carcinomatosis

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