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Sponsored by: |
Mundipharma Research Limited |
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Information provided by: | Mundipharma Research Limited |
ClinicalTrials.gov Identifier: | NCT00854867 |
The purpose of this study is to demonstrate the safety of giving Whole Brain Radiotherapy (WBRT) together with intrathecal liposomal cytarabine (DepoCyte®) for patients with leptomeningeal metastases. The study will compare the safety of giving DepoCyte at the same time as WBRT with giving the drug after WBRT is complete.
Condition | Intervention | Phase |
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Solid Tumour Neoplastic Meningitis Brain Metastases |
Drug: Liposomal cytarabine intrathecal (DepoCyte) Radiation: Whole Brain Radiotherapy (WBRT) |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase I Randomised Multi-centre Study to Demonstrate the Safety of WBRT Concomitant to Intrathecal Liposomal Cytarabine (DepoCyte®) Versus WBRT & Sequential Intrathecal Liposomal Cytarabine (DepoCyte®) for Treatment of STNM With or Without Brain Metastasis. |
Estimated Enrollment: | 30 |
Study Start Date: | May 2009 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Indication and Criteria for Inclusion/Exclusion:
Subjects who are to be included in the study have to meet all of the following criteria:
(If a flow abnormality is initially demonstrated but the flow block is subsequently documented by another flow study or MRI scan to be relieved following limited field radiation therapy, the subject may then be eligible)
Laboratory values as follows:
LDH less than or equal to 3 x upper limit of normal
Exclusion Criteria:
Contact: Jill Kiteley | info@contact-clinical-trials.com | |
Contact: Margaret C Wilson | info@contact-clinical-trials.com |
Study ID Numbers: | DEP1501, 2008-007206-10 |
Study First Received: | March 2, 2009 |
Last Updated: | July 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00854867 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
Solid tumour neoplastic meningitis STNM leptomeningeal metastases DepoCyte |
WBRT Whole Brain Radiotherapy Liposomal cytarabine intrathecal Solid Tumour Neoplastic Meningitis with or without brain metastasis |
Antimetabolites Anti-Infective Agents Immunologic Factors Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Antiviral Agents |
Immunosuppressive Agents Meningitis Brain Neoplasms Central Nervous System Infections Neoplasm Metastasis Nervous System Neoplasms Cytarabine |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Central Nervous System Neoplasms Brain Diseases Meningitis Neoplastic Processes Neoplasms by Site Pathologic Processes |
Therapeutic Uses Neoplasm Metastasis Nervous System Neoplasms Cytarabine Nervous System Diseases Central Nervous System Diseases Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Brain Neoplasms Neoplasms Central Nervous System Infections |