Solid Tumour Neoplastic MeningitisPhase 1NCT00854867
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.
A Phase 1 study testing Whole Brain Radio Therapy (WBRT) with sequential Depocyte and Whole brain radiotherapy (WBRT) with concomitant Depocyte in people with Solid Tumour Neoplastic Meningitis and Brain Metastases, run by Mundipharma Research Limited at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumour Neoplastic Meningitis, Brain Metastases
- What is being tested?
- Whole Brain Radio Therapy (WBRT) with sequential Depocyte and Whole brain radiotherapy (WBRT) with concomitant Depocyte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Feb 2011to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Austria6 sites
Feldkirch Regional Hospital
Feldkirch
Graz Medical University
Graz
Univeristy Clinic for Radiotherapy and Radio-Oncology
Innsbruck
Klagenfurt Regional Hospital
Klagenfurt
University Internal Medicine Clinic III
Salzburg
Kaiser-Franz-Josef-Spital
Vienna
About this 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.
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.
- Being tested
- Whole Brain Radio Therapy (WBRT) with sequential Depocyte, Whole brain radiotherapy (WBRT) with concomitant Depocyte
- Keywords
- Solid tumour neoplastic meningitis, STNM, leptomeningeal metastases, DepoCyte, WBRT, Whole Brain Radiotherapy, Liposomal cytarabine intrathecal, Solid Tumour Neoplastic Meningitis with or without brain metastasis
- Medical subject headings
- Brain Neoplasms, Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Brain Radio Therapy (WBRT) with sequential DepocyteDrug
Whole brain radiotherapy (WBRT) with concomitant DepocyteDrug
| Study group | Role | What they receive |
|---|---|---|
| Whole brain radiotherapy (WBRT) with concomitant Depocyte | Experimental | 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. Receives: Drug: Whole brain radiotherapy (WBRT) with concomitant Depocyte |
| Whole Brain Radio Therapy (WBRT) with sequential Depocyte | Active comparator | 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. Receives: Drug: Whole Brain Radio Therapy (WBRT) with sequential Depocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis.
Measured: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Secondary outcomes (4)
Overall response rate (ORR)
Measured: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Progression free survival (PFS)
Measured: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Time to neurologial progression (TNP)
Measured: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Overall survival (OS)
Measured: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startFeb 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumour Neoplastic MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854867
- Sponsor's protocol ID
- DEP1501
- Other IDs
- 2008-007206-10, 2008
- Status last verified
- Feb 2013
- First submitted
- 2 Mar 2009
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00854867
- Acronym / sponsor ID
- DEP1501
- Keywords
- Solid tumour neoplastic meningitis, STNM, leptomeningeal metastases, DepoCyte, WBRT, Whole Brain Radiotherapy, Liposomal cytarabine intrathecal, Solid Tumour Neoplastic Meningitis with or without brain metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole brain radiotherapy (WBRT) with concomitant Depocyte | Experimental | Drug: Whole brain radiotherapy (WBRT) with concomitant DepocyteSubjects 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 | Active comparator | Drug: Whole Brain Radio Therapy (WBRT) with sequential DepocyteSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Brain Radio Therapy (WBRT) with sequential Depocyte | Drug | Whole Brain Radio Therapy (WBRT) with sequential Depocyte |
| Whole brain radiotherapy (WBRT) with concomitant Depocyte | Drug | Whole brain radiotherapy (WBRT) with concomitant Depocyte |
Primary outcome
To demonstrate that WBRT concomitant to DepoCyte is as safe as WBRT & sequential DepoCyte in treating solid tumour neoplastic meningitis with/without brain metastasis.
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
4 secondary outcomes
Overall response rate (ORR)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Progression free survival (PFS)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Time to neurologial progression (TNP)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Overall survival (OS)
Time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Results available on websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Whole Brain Radio Therapy (WBRT) with sequential Depocyte and Whole brain radiotherapy (WBRT) with concomitant Depocyte in people with Solid Tumour Neoplastic Meningitis and Brain Metastases, run by Mundipharma Research Limited at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: Safety is reviewed at every visit & for 3 months after last Depocyte administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.