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.
Phase 1
Completed
- Conditions
- Solid Tumour Neoplastic MeningitisBrain Metastases
- Interventions
- Drug: Whole brain radiotherapy (WBRT) with concomitant DepocyteDrug: Whole Brain Radio Therapy (WBRT) with sequential Depocyte
- Registration Number
- NCT00854867
- Lead Sponsor
- Mundipharma Research Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Whole brain radiotherapy (WBRT) with concomitant Depocyte Whole brain radiotherapy (WBRT) with concomitant Depocyte Subjects will receive a total of 38.4 Gray (Gy) WBRT given over 4 weeks. Subjects will receive 3 GyWBRT on Days 1 and 2 and then 1.8 Gy on the third fourth and fifth days of WBRT treatment during Week 1. Subjects will then receive 1.8 Gy WBRT per day; 5 days out of seven, each week for the next 3 weeks. A total of 4 doses of DepoCyte (50 mg of liposomal ARA-C) will be administered intrathecally. The first dose will be administered on Day 3 (or Day 4 or 5) of Week 1, i.e. the third day of radiotherapy treatment when the dosage is reduced to 1.8 Gy. The second dose will be administered on Day 17(+2 days); the third dose will be administered on Day 31 (+2 days); the fourth dose will be administered on Day 45 (+2 days) to complete the induction phase of the protocol. Subjects will continue to receive an additional 6 doses of DepoCyte one dose every 28 days (+2 days) during the maintenance period. The first dose will be given 28 days after the last dose in the induction phase. Whole Brain Radio Therapy (WBRT) with sequential Depocyte Whole Brain Radio Therapy (WBRT) with sequential Depocyte Subjects will receive a total of 38.4 Gy WBRT given over 4 weeks. Subjects will receive 3 Gy (WBRT on Day 1 and Day 2) and then 1.8 Gy on the third fourth and fifth days of WBRT treatment during Week 1. Subjects will then receive 1.8 Gy WBRT per day; 5 days out of seven, each week for the next 3 weeks. A total of 4 doses of DepoCyte (50 mg of liposomal ARA-C) will be administered intrathecally. The first dose will be administered on Day 29 (+2 days); the second dose will be administered on Day 43(+2 days); the third dose will be administered on Day 57 (+2 days); the fourth dose will be administered on Day 71 (+2 days) to complete the induction phase of the protocol. DepoCyte should never be administered more frequently than every 14th day. Subjects will continue to receive an additional 6 doses of DepoCyte one dose every 28 days (+2 days) during the maintenance period. The first dose will be given 28 days after the last dose in the induction phase.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Overall response rate (ORR) Safety is reviewed at every visit & for 3 months after last Depocyte administration Progression free survival (PFS) Safety is reviewed at every visit & for 3 months after last Depocyte administration Time to neurologial progression (TNP) Safety is reviewed at every visit & for 3 months after last Depocyte administration Overall survival (OS) Safety is reviewed at every visit & for 3 months after last Depocyte administration
Trial Locations
- Locations (6)
Kaiser-Franz-Josef-Spital
🇦🇹Vienna, Austria
University Internal Medicine Clinic III
🇦🇹Salzburg, Austria
Klagenfurt Regional Hospital
🇦🇹Klagenfurt, Austria
Graz Medical University
🇦🇹Graz, Austria
Feldkirch Regional Hospital
🇦🇹Feldkirch, Austria
Univeristy Clinic for Radiotherapy and Radio-Oncology
🇦🇹Innsbruck, Austria