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
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital, Bonn
Collaborator:
Mundipharma Research GmbH & Co KG
Information provided by (Responsible Party):
Dr. Martin Glas, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01563614
First received: March 9, 2012
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leptomeningeal Metastasis From Malignant Melanoma |
Radiation: Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS) Drug: Lomustine Drug: Liposomal cytarabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Liposomal Cytarabine in Combination With Radiotherapy (RT) and Lomustine for the Treatment of Leptomeningeal Metastasis From Malignant Melanoma |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bonn:
Primary Outcome Measures:
- Safety/Tolerance [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]The primary endpoint is safety and tolerance and will be based on the frequency and severity of adverse events.
Secondary Outcome Measures:
- Delay of treatments [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]Frequency and median time of delay of each of the treatments (lomustine, liposomal cytarabine, radiotherapy).
- Response rate [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]Overall response rate determined by clinical, MRI- and CSF-cytological assessment criteria.
- Progression [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]Neurological progression, progression free survival, overall survival.
| Estimated Enrollment: | 9 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563614
Locations
| Germany | |
| Neurologische Universitaetsklinik Bonn | |
| Bonn, Germany, 53127 | |
Sponsors and Collaborators
University Hospital, Bonn
Mundipharma Research GmbH & Co KG
Investigators
| Principal Investigator: | Martin Glas, PD Dr. | Neurologische Universitaetsklinik Bonn |
More Information
No publications provided
| Responsible Party: | Dr. Martin Glas, Deputy Director Division of Clinical Neurooncology Unit, University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT01563614 History of Changes |
| Other Study ID Numbers: | DepoRaCe |
| Study First Received: | March 9, 2012 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Melanoma Neoplasm Metastasis Meningeal Carcinomatosis Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Neoplastic Processes Pathologic Processes Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Nervous System Diseases Cytarabine Lomustine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013