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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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumour Neoplastic Meningitis, Brain Metastases

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Trial Information

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis.

Outcome Time Frame:

Safety is reviewed at every visit & for 3 months after last Depocyte administration

Safety Issue:

Yes

Authority:

Austria: Agency for Health and Food Safety

Study ID:

DEP1501

NCT ID:

NCT00854867

Start Date:

February 2011

Completion Date:

October 2012

Related Keywords:

  • Solid Tumour Neoplastic Meningitis
  • Brain Metastases
  • Solid tumour neoplastic meningitis
  • STNM
  • leptomeningeal metastases
  • DepoCyte
  • WBRT
  • Whole Brain Radiotherapy
  • Liposomal cytarabine intrathecal
  • Solid Tumour Neoplastic Meningitis with or without brain metastasis
  • Meningitis
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms
  • Meningeal Carcinomatosis
  • Neoplasms

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