Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Approved-not yet active	18 and over	Pharmaceutical / Industry	2008-007206-10 DEP1501, NCT00854867

Trial Description

Summary

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Mundipharma International Limited

Jill Kiteley
		Email: info@contact-clinical-trials.com

Margaret C Wilson
		Email: info@contact-clinical-trials.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00854867
Information obtained from ClinicalTrials.gov on March 18, 2009