Full Text View
Tabular View
No Study Results Posted
Related Studies
Study to Demonstrate the Safety of WBR Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyte®) Versus Intrathecal Liposomal Cytarabine (DepoCyte®) Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastasis.
This study is not yet open for participant recruitment.
Verified by Mundipharma Research Limited, March 2009
First Received: March 2, 2009   Last Updated: July 23, 2009   History of Changes
Sponsored by: Mundipharma Research Limited
Information provided by: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT00854867
  Purpose

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
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.

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis. Safety is reviewed at every visit & for 3 months after last Depocyte administration

Secondary Outcome Measures:
  • Overall response rate;Progression free survival; Time to neurological progression; Overall survival; Mini Mental State Examination; Health Questionnaires EORTC QLQ-C30 & EORTC QLQ-BN20

Estimated Enrollment: 30
Study Start Date: May 2009
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Indication and Criteria for Inclusion/Exclusion:

Subjects who are to be included in the study have to meet all of the following criteria:

  • Informed consent
  • Male and female, age over 18 years
  • Solid tumour neoplastic meningitis as demonstrated by a positive lumbar CSF cytology (obtained within 21 days prior to treatment initiation) OR Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI indicating the presence of meningeal tumour (diagnosis to be made by neuro-oncologist and confirmed / signed within the CRF). All MRIs will be forwarded for central review and confirmation of diagnosis. In case of discrepancy the central review overrides the assessment of the investigator.
  • CSF flow abnormality excluded by either an MRI scan or a 99Tc-DTPA or 111In-DTPA flow study.

(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)

  • If brain metastasis confirmed (including subjects who have had previous stereotactical radiosurgery or solitary lesion brain surgery) the lesion should be less than 3cm diameter
  • Mini Mental State Examination (MMSE) score more than 24
  • ECOG performance status 0-2

Laboratory values as follows:

  • Platelet count more than or equal to 80,000/mm3
  • ANC more than or equal to 1,000/mm3
  • Serum creatinine less than or equal to 2 x upper limit of normal
  • Total bilirubin less than or equal to 3 x upper limit of normal
  • SGOT (AST) less than or equal to 3 x upper limit of normal
  • LDH less than or equal to 3 x upper limit of normal

    • Females of child-bearing potential must have a negative (urine or serum) pregnancy test within 21 days prior to the start of study treatment.
    • Females of childbearing potential must be willing to use an effective method of contraception to prevent pregnancy for the duration of the study (e.g. implants, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomised partner).
    • Males must be willing to use an effective method of contraception with their partner to prevent pregnancy for the duration of the study (e.g. implants, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence or vasectomy).

Exclusion Criteria:

  • Previous WBRT
  • Brain metastases more than 3 cm diameter
  • Previous IT treatment
  • Uncontrolled infection including HIV infection
  • Any present condition that is regarded as contraindication for WBRT and intrathecal chemotherapy
  • Prior treatment with systemic ARA-C
  • Anticipated hypersensitivity to DepoCyte or ARA-C
  • Clinically manifest encephalopathy
  • On anticoagulant therapy
  • Ventricular peritoneal CSF drain in situ
  • Subjects unable to comply with study procedures
  • Pregnancy and lactation Any other investigational drug administered within 21 days prior to study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854867

Contacts
Contact: Jill Kiteley info@contact-clinical-trials.com
Contact: Margaret C Wilson info@contact-clinical-trials.com

Sponsors and Collaborators
Mundipharma Research Limited
  More Information

No publications provided

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

Keywords provided by Mundipharma Research Limited:
Solid tumour neoplastic meningitis
STNM
leptomeningeal metastases
DepoCyte
WBRT
Whole Brain Radiotherapy
Liposomal cytarabine intrathecal
Solid Tumour Neoplastic Meningitis with or without brain metastasis

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009