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 | Terminated Phase 1

• 1 other identifier: DepoRaCe
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety/Tolerance

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

  30 weeks

Secondary Outcomes (3)

• Delay of treatments

  30 weeks

• Response rate

  30 weeks

• Progression

  30 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS); Drug: Lomustine; Drug: Liposomal cytarabine

Interventions

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

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Treatment

Lomustine DRUG

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Treatment

Liposomal cytarabine DRUG

Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead
• Mundipharma Research GmbH & Co KG: collaborator

Study Sites (1)

Neurologische Universitaetsklinik Bonn

Bonn, 53127, Germany

Location

MeSH Terms

Interventions

Lomustine

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Martin Glas, PD Dr.

  Neurologische Universitaetsklinik Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director Division of Clinical Neurooncology Unit

Study Record Dates

• First Submitted: March 9, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

DE (1)